Drawstring Bag 13in x 12in BAGDS1312

GUDID 00848530089061

Drawstring Bag 13in x 12in

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable
Primary Device ID00848530089061
NIH Device Record Keya539e9f3-049b-4aac-b3d1-cd099b231767
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrawstring Bag 13in x 12in
Version Model NumberBAGDS1312
Catalog NumberBAGDS1312
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530089061 [Primary]
GS110848530089068 [Package]
Package: [600 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-24

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

10848530107335 - Invacare PerfectO2 Cabinet Access Door 2025-09-25 Replacement part for the Invacare PerfectO2 Cabinet Access Door - OEM# 1161831
10848530107342 - Invacare Platinum Filter Access Door 2025-09-25 Replacement part for Invacare Platinum Filter Access Door OEM# 110667
10848530107359 - Invacare F-Tube, PVC for PerectO2 and PerfectO2V 2025-09-25 Replacement Part Invacare F-Tube, PVC for PerectO2 and PerfectO2V OEM# 1143446
10848530107366 - Invacare Panel Control for PerfectO2 and PerfectO2V 2025-09-25 Replacement Part Invacare Panel Control for PerfectO2 and PerfectO2V OEM# 1143469
10848530107373 - Drive Power Cord2025-09-25 Replacement part for Drive Power Cord
10848530107380 - Drive Capacitor DS SSP 10L 2025-09-25 Replacement part for Drive Capacitor DS SSP 10L
00848530107390 - React Compressor 2025-09-25 Replacement for React Compressor
00848530107406 - React Compressor Seal - Piston Ring 2025-09-25 Replacement part for React Compressor Seal - Piston Ring

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