FDA.reportPublic FDA data

SmartPump

Primary DI
07613154589647
Brand
SmartPump
Company
STRYKER CORPORATION
Model
5920011000
Catalog number
5920-011-000
Device description
Dual Channel Pump
Published
2017-09-22
Public version status
Update
Distribution status
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
07613154589647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154589647076131545896477613154589647

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29

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