n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 14250105614043
• Version / Model: 14-22-600
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 3
• Public Version Date: 2022-09-19
• Public Version Status: Update
• Public Device Record Key: dea66f14-d321-4e36-990b-cb7b37f83357
• Distribution End Date: 2022-09-16

Device Description

Tourniquet 6000

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	878.5910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14074	Surgical pneumatic tourniquet system	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	04250105614046	GS1
Primary	14250105614043	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius