NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691718330
• Version / Model: Gas bottle holder f. helicopter HKH 8880
• Catalog Number: 70105.0901
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-29
• Public Version: 5
• Public Version Date: 2024-12-11
• Public Version Status: Update
• Public Device Record Key: ac1557e7-ecd9-442d-a67b-6a0d3186d03f
• Distribution End Date: 2024-09-25

Device Description

Gas bottle holder for helicopter.

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: No
• 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
DTQ	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS	Cardiovascular	870.4220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35954	Medical device rail	A device in the form of a narrow bar designed to be fixed on the wall for mounting and organizing medical devices [e.g., in hospital wards, treatment rooms, intensive care units (ICU)]; the equipment to be supported is not included. It may be used in conjunction with clamps and/or poles. It is available in various lengths.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691718330	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102726	000