n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 14250105608394
• Version / Model: 52-01-300
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-26
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: d71c235c-9799-47ef-9d6e-b48a68da6ec7

Device Description

Pressure Infusion Cuff 3000 / 5000 ml; for irrigation purposes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	880.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13100	Intravenous pressure infusor, manual, reusable	A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	04250105608397	GS1
Primary	14250105608394	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