Universal Neoprene Chinstrap CS001

GUDID 00848530080013

Universal Neoprene Chinstrap. Can be used with any nasal mask or nasal pillows, one size fits most.

SUNSET HEALTHCARE SOLUTIONS, INC.

Anaesthesia mask strap, reusable
Primary Device ID00848530080013
NIH Device Record Key9ef424e3-289c-46e8-9850-d064b791267f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Neoprene Chinstrap
Version Model NumberCS001
Catalog NumberCS001
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

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530080013 [Primary]
GS110848530080010 [Package]
Package: [250 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 Date2018-08-31
Device Publish Date2018-07-31

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