FDA.reportPublic FDA data

SmartPump

Primary DI
04546540617132
Brand
SmartPump
Company
STRYKER CORPORATION
Model
5920012000
Catalog number
5920-012-000
Device description
Printer
Published
2017-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCYTOURNIQUET, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540617132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540617132045465406171324546540617132

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic tourniquet systemA device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327651188VersiQuad0234112600234-112-6002026-07-22
07613252193791Neuroform3M003SNF325150M003SNF3251502015-05-29
07613252193845Neuroform3M003SNF335100M003SNF3351002015-05-29
07613252193913Neuroform3M003SNF345100M003SNF3451002015-05-29
07613154599127NA59200002045920-000-2042018-09-24
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
08809802644052Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644069Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644076Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644083Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644090Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644106Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644113Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644120Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644137Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644144Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644151Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644168Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644175Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644182Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644199Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644205Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644212Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644229Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
96973521872753N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-06-12
96973521872777N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-06-12
96973521872272N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-05-31
96973521872289N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-05-31