n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04250105612554
• Version / Model: 20-11-111-1
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-08
• Public Version: 2
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: ad2b392b-cf45-4cb3-8767-b82d333a1168
• Distribution End Date: 2023-09-20

Device Description

Cover for Tourniquet Cuff small

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
35925	Tourniquet cuff, single-use	A 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14250105612551	GS1		50	Not in Commercial Distribution	2023-09-20
Primary	04250105612554	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep dry, keep away from sunlight and heat