Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3006783779
Manufacturer Name: Hangzhou Hua'An Medical & Health
Manufacturer address line 1: Bldg 2, Baimiao Ind. Park
Manufacturer address line 2:
Manufacturer City: Wuchang
Manufacturer Province/state:
Manufacturer Country: China
Product code: 74D--SK
Importers product description: 864537159969 BLOOD PRESSURE MONITOR
Refusal date: 05-MAY-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-2421764-9/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
NO 510(K)
Manufacturer FEI: 3005124466
Manufacturer Name: Panasonic Logistics (Hong Kong)
Manufacturer address line 1: Chinachem Golden Plaza, 77 Mody Roadco.,
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 74D--XN
Importers product description: ELECTRONIC BLOOD PRESSURE METER - FOR EXPORT ONLY
Refusal date: 27-MAY-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 406-0416607-0/1/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 3005402451
Manufacturer Name: Mabis Healthcare Inc
Manufacturer address line 1: 1931 Norman Dr S
Manufacturer address line 2:
Manufacturer City: Park City
Manufacturer Province/state: IL
Manufacturer Country: United States
Product code: 74D--XQ
Importers product description: BLOOD PRESSURE CUFF FOR UAL MEDICAL KIT FOR INFLIGHT USE
Refusal date: 23-MAY-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360913-8/1/22/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
DE/RX KIT
Manufacturer FEI: 3003757231
Manufacturer Name: Plexus Manufacturing Sdn Bhd
Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
Manufacturer address line 2:
Manufacturer City: Penang
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 74D--XY
Importers product description: CARELINK MONITOR FOR CANADA
Refusal date: 29-MAY-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 004-5011517-5/2/1/
Carrier: EVA AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006316319
Manufacturer Name: Medrad Inc
Manufacturer address line 1: 100 Global View Dr
Manufacturer address line 2:
Manufacturer City: Warrendale
Manufacturer Province/state: PA
Manufacturer Country: United States
Product code: 74I--ZQ
Importers product description: CONTRAST DELIVERY INJECTOR FOR EXPORT ONLY
Refusal date: 23-MAY-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: DM9-8010501-7/1/1/
Carrier: BRITISH AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 3005402451
Manufacturer Name: Mabis Healthcare Inc
Manufacturer address line 1: 1931 Norman Dr S
Manufacturer address line 2:
Manufacturer City: Park City
Manufacturer Province/state: IL
Manufacturer Country: United States
Product code: 74L--DE
Importers product description: STETHOSCOPE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
Refusal date: 23-MAY-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360913-8/1/23/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
DE/RX KIT
Manufacturer FEI: 3005516812
Manufacturer Name: Spectraytics
Manufacturer address line 1: 145 3rd Street South
Manufacturer address line 2:
Manufacturer City: Dassel
Manufacturer Province/state: MN
Manufacturer Country: United States
Product code: 74N--IQ
Importers product description: 864594750596 STENT
Refusal date: 13-MAY-2008
FDA_District: SAN-DO
Entry/doc/line/sfx: 112-2561302-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3003757231
Manufacturer Name: Plexus Manufacturing Sdn Bhd
Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
Manufacturer address line 2:
Manufacturer City: Penang
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 74N--VZ
Importers product description: CARELINK MONITOR FOR CANADA (IFE)
Refusal date: 29-MAY-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 004-5011564-7/1/1/
Carrier: EVA AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003757231
Manufacturer Name: Plexus Manufacturing Sdn Bhd
Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
Manufacturer address line 2:
Manufacturer City: Penang
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 74N--VZ
Importers product description: CARELINK MONITOR FOR CANADA (IFE)
Refusal date: 29-MAY-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 004-5011517-5/1/1/
Carrier: EVA AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003757231
Manufacturer Name: Plexus Manufacturing Sdn Bhd
Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
Manufacturer address line 2:
Manufacturer City: Penang
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 74N--VZ
Importers product description: MODEL 2490C0022K CARELINK MONITOR
Refusal date: 29-MAY-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 004-5011251-1/1/1/
Carrier: EVA AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED