RESUSCITATION ACCESSORY

GUDID 00848530105013

Sunset Disposable Pressure Manometer, L-Shape - 25PCS

SUNSET HEALTHCARE SOLUTIONS, INC.

Airway pressure monitor, non-powered
Primary Device ID00848530105013
NIH Device Record Keye3d6495c-e54e-4230-82a5-06031f386201
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESUSCITATION ACCESSORY
Version Model NumberRES8201LNS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530105013 [Primary]

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-28
Device Publish Date2025-08-20

On-Brand Devices [RESUSCITATION ACCESSORY]

00848530105013Sunset Disposable Pressure Manometer, L-Shape - 25PCS
00848530105006Sunset Disposable PEEP Valve, 5-20cm H20, 15mm ID

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