Preemie Transport Blanket

Basic Information

• Brand Name: Preemie Transport Blanket
• Primary DI: 00714646000484
• Version / Model: 1126
• Catalog Number: 1126
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2023-07-19
• Public Version: 1
• Public Version Date: 2023-07-27
• Public Version Status: New
• Public Device Record Key: ae3c522e-c440-41fe-8d57-ed46f613dd21

Device Description

Preemie Transport Blanket, Very Low Birth Weight Blankets - 15ct

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: 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: 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
KME	BEDDING, DISPOSABLE, MEDICAL	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58934	Infant blanket, single-use	A piece of fabric material intended to be used to wrap newborns/infants to retain their body heat and/or absorb fluids. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10714646000481	GS1
Primary	00714646000484	GS1

Customer Contacts

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