Pediatric Headstrap

Basic Information

• Brand Name: Pediatric Headstrap
• Primary DI: 00859290006397
• Version / Model: 90518
• Catalog Number: 90518
• Company Name: TRUER MEDICAL, INC.
• Labeler DUNS: 003530786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-30
• Public Version: 1
• Public Version Date: 2022-07-08
• Public Version Status: New
• Public Device Record Key: cccb9abd-c3eb-42db-bff6-0955783c4a50

Device Description

The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing between the holes on the straps, these designs allow for a wide range of locations to secure the straps to any sized individual.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTK	Strap, Head, Gas Mask	Anesthesiology	868.5560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37476	Anaesthesia mask stabilizer, reusable	A device designed to secure an anaesthesia mask on the face of a patient typically by providing anchorage for the fixation of the mask's headstrap. It is typically a ring or circular band with a number of hooks spaced around its outer edge, which is placed over the connector port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859290006397	GS1

Customer Contacts

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