FDA.report

n.a.

Primary DI
04250105613100
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
20-74-715
Device description
Single Slim-Cuff for lower leg/arm, contour shape
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KCYTourniquet, Pneumatic

Product Code Classifications

CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250105613100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250105613100042501056131004250105613100

GMDN Terms

TermDefinition
Tourniquet cuff, reusableA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a reusable device.

Device Sizes

TypeValueUnit
Length18Inch
Length46Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight and heat

Sterilization Methods

Method

Contacts

PhoneEmail
+49745495960info@vbm-medical.de

Regulatory Flags

DUNS number
324869601
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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14250105630449Ambu® SureSight TM Stylet; medium3219000202025-07-02
14250105630456Ambu® SureSight TM Stylet; large32190002302025-07-02
14250105628118n.a.30-08-447-12020-11-09
24250105630521Paediatric Mask; Newborn88-11-0002025-04-25
24250105630538Paediatric Mask; Infant88-11-0012025-04-25
24250105630545Paediatric Mask; Child88-11-0022025-04-25
04250105630299Sampling Line61-99-1502025-04-15
14250105630302Sampling Line61-99-2002025-04-15
04250105630312Sampling Line61-99-3002025-04-15
04250105630329Right Angled Connector60-60-0022025-04-15
14250105630333Right Angled Connector60-60-0042025-04-15
14250105630340Right Angled Connector60-60-0102025-04-15
14250105630357Right Angled Connector60-60-2052025-04-15
04250105630367Right Angled Connector60-60-3052025-04-15
14250105630371Right Angled Connector60-60-0052025-04-15
04250105609660n/a20-10-3332019-10-08
04250105629798Bronchoscope Airway30-40-420-12024-11-04
04250105629804Bronchoscope Airway30-40-440-12024-11-04
04250105629415Clear Infusor57-02-3002023-01-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set Delfi Medical Innovations IncKCY2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M995995000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000421Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
08809802646971DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646988DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646995DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
M99592500002BFR1PTS for BFR Generation 3 - Dual Channel SystemDelfi Medical Innovations IncKCY2025-06-17
16976514770009Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770016Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770023Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770030Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770047Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770054Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770061Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770078Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770085Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770092Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770108Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770115Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770122Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23