Tourniquet 4500

GUDID 04250105606348

VBM Medizintechnik GmbH

Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system
Primary Device ID04250105606348
NIH Device Record Key118088cc-aadd-4c84-877f-0c3f12d37699
Commercial Distribution StatusIn Commercial Distribution
Brand NameTourniquet 4500
Version Model Number19-12-500
Company DUNS324869601
Company NameVBM Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de
Phone+49745495960
Emailinfo@vbm-medical.de

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104250105606348 [Direct Marking]
GS114250105606345 [Primary]

FDA Product Code

KCYTourniquet, Pneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-02
Device Publish Date2022-04-22

Devices Manufactured by VBM Medizintechnik GmbH

04250105630039 - Tourniquet Silicone Cuff; Double Cuff2024-07-09 30 cm / 12 inch
14250105630258 - Tourniquet Drape; small2024-07-05 18 - 45 cm
14250105630265 - Tourniquet Drape; large2024-07-05 40 - 80 cm
04250105630275 - Tourniquet Drape; small2024-07-05 18 - 45 cm
14250105630289 - Tourniquet Drape; large2024-07-05 40 - 80 cm
04250105630046 - Tourniquet Silicone Cuff; Double Cuff2024-07-05 46 cm / 18 inch
04250105630053 - Tourniquet Silicone Cuff; Double Cuff2024-07-05 61 cm / 24 inch
04250105630091 - Tourniquet Silicone Cuff; Single Cuff2024-07-05 86 cm / 34 inch

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.