Babyflow Disposable US/CA

Basic Information

• Brand Name: Babyflow Disposable US/CA
• Primary DI: 04048675027997
• Version / Model: 8418582
• Company Name: Drägerwerk AG & Co. KGaA
• Labeler DUNS: 315578914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 36d7ada5-d690-469a-b523-068a2c94f6f5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
CAT	Cannula, Nasal, Oxygen	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35202	Nasal oxygen cannula, CPAP	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048675027997	GS1
Unit of Use	04048675429104	GS1

Customer Contacts

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