FDA.reportPublic FDA data

n.a.

Primary DI
04250105609677
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
20-10-442
Device description
Coil Connecting Tubing; red; with spring
Published
2020-01-21
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
04250105609677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250105609677042501056096774250105609677

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep away from sunlight and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49745495960info@vbm-medical.de

Regulatory Flags#

DUNS number
324869601
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250105630770ScalpelCric30-08-447-12026-05-08
04250105623048n.a.33-80-650-12020-09-02
04250105624243n.a.33-81-650-12020-09-02
04250105605150Quicktrach I30-04-002-12026-04-23
04250105605167Quicktrach I30-04-004-12026-04-23
04250105612462Quicktrach I30-04-904-12026-04-23
04250105613292Quicktrach I30-04-902-12026-04-23
14250105606024Tourniquet 250015-12-5002022-06-27
04250105630459Ambu® SureSight TM Stylet; large3219000302025-07-02
04250105630442Ambu® SureSight TM Stylet; medium3219000202025-07-02
04250105630435Ambu® SureSight TM Stylet; small3219000102025-07-02
14250105630449Ambu® SureSight TM Stylet; medium3219000202025-07-02
14250105630456Ambu® SureSight TM Stylet; large32190002302025-07-02
04250105628111n.a.30-08-447-12020-11-09
14250105628118n.a.30-08-447-12020-11-09
14250105630524Paediatric Mask; Newborn88-11-0002025-04-25
14250105630531Paediatric Mask; Infant88-11-0012025-04-25
14250105630548Paediatric Mask; Child88-11-0022025-04-25
24250105630521Paediatric Mask; Newborn88-11-0002025-04-25
24250105630538Paediatric Mask; Infant88-11-0012025-04-25

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