Numobag Kit

Basic Information

• Brand Name: Numobag Kit
• Primary DI: 00860010630600
• Version / Model: NBC952
• Company Name: Numotech, Inc.
• Labeler DUNS: 193561185
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-11
• Public Version: 1
• Public Version Date: 2023-07-19
• Public Version Status: New
• Public Device Record Key: df71cc8f-1b09-4ab4-9499-0ec92160deee

Device Description

Extremity-oxygenation hyperbaric chamber, non-powered

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	878.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47188	Extremity-oxygenation hyperbaric chamber, non-powered	A small vessel intended to hermetically surround a patient's limb for the topical application of oxygen (O2) from an O2 gas supply at a pressure slightly greater than atmospheric (e.g., 1 to 2 atm) during hyperbaric oxygen therapy (HBOT). The device is typically a rigid or flexible plastic shell with valves and tubing for connection to an O2 source. It is typically used to treat skin ulcerations, decubitus ulcers, infected stumps, skin grafts, burns, and frostbite.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010630600	GS1

Customer Contacts

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