Sunset Red Style Chin Strap – Fully Adjustable-Extra Large CS007-ADJXL

GUDID 10848530082434

Sunset Red Style Chin Strap – Fully Adjustable-Extra Large

SUNSET HEALTHCARE SOLUTIONS, INC.

Anaesthesia mask strap, reusable
Primary Device ID10848530082434
NIH Device Record Key280031b0-9619-4198-b69e-b4d91072bfcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Red Style Chin Strap – Fully Adjustable-Extra Large
Version Model NumberCS007-ADJXL
Catalog NumberCS007-ADJXL
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530082437 [Primary]
GS110848530082434 [Package]
Contains: 00848530082437
Package: [70 Units]
In Commercial Distribution

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 Date2018-10-18
Device Publish Date2018-09-17

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530106966 - Tracheostomy and Suction Accessory2025-08-22 18fr Chimney, Straight Packed Catheter
10848530106970 - Tracheostomy and Suction Accessory2025-08-22 6fr Chimney, Straight Packed Catheter - Delee
10848530106987 - Tracheostomy and Suction Accessory2025-08-22 8fr Chimney, Straight Packed Catheter - Delee
10848530106994 - Tracheostomy and Suction Accessory2025-08-22 10fr Directional, Straight Packed Catheter
10848530107007 - Tracheostomy and Suction Accessory2025-08-22 12fr Directional, Straight Packed Catheter
10848530107014 - Tracheostomy and Suction Accessory2025-08-22 8fr Directional, Straight Packed Catheter - Delee
10848530107021 - Suction Kit2025-08-22 10fr Chimney Catheter, Gloves, Cup - KIT
10848530107038 - Suction Kit2025-08-22 12fr Chimney Catheter, Gloves, Cup - KIT

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.