Pediatric Headstrap 90518

GUDID 00859290006397

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.

TRUER MEDICAL, INC.

Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable Anaesthesia mask stabilizer, reusable
Primary Device ID00859290006397
NIH Device Record Keycccb9abd-c3eb-42db-bff6-0955783c4a50
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Headstrap
Version Model Number90518
Catalog Number90518
Company DUNS003530786
Company NameTRUER MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com
Phone7146289785
Emailttruitt@truermedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859290006397 [Primary]

FDA Product Code

BTKStrap, Head, Gas Mask

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

Devices Manufactured by TRUER MEDICAL, INC.

00859290006472 - HP to 3.5mm Phonojack Cable with Shrinkwrap2024-01-24 HP to 3.5mm Phonojack Cable with Shrinkwrap
10859290006462 - Truer Bougie Coiled2023-10-02 Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.
00859290006441 - 400 Series Right Angle Cable (80 cm)2023-07-27 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera
00859290006458 - 400 Series Right Angle Cable (160 cm)2023-07-27 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera
10859290006417 - Nasal Cannula 2022-09-16 Adult Nasal Cannula w/7' safety channel tubing
00859290006236 - Truer Bougie2022-09-06 Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medica
00859290006366 - HP 400 series type monitor cable2022-07-14 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera
00859290006373 - 400 Series Type Monitor Cable, Right Angle2022-07-14 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.