Infant Heel Snuggler

Basic Information

• Brand Name: Infant Heel Snuggler
• Primary DI: 00850018561600
• Version / Model: 99047
• Catalog Number: 99047
• Company Name: INTERNATIONAL BIOMEDICAL, LTD.
• Labeler DUNS: 073179368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 19e7be2b-2cda-465e-a1c9-b6d5dde436e8

Device Description

Infant Heel Snuggler

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: No
• 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
MPO	Infant Heel Warmer (Chemical Heat Pack)	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58416	Activated-medium surgical warming blanket	A non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover. It is a highly hygienic device made of plastic material and designed with integrated pockets that hold air-activated warming pads containing various media [e.g., active coal, clay, or salt and iron (Fe) powder] that chemically generate heat when the device is removed from its sealed packaging. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850018561600	GS1

Premarket Submissions

Submission Number	Supplement Number
K221154	000