Respiratory Kit

GUDID 00848530106294

Respiratory Kit - Large 1 kit contains: (4) RES1107, (2) RES012, (1) RES031, (1) RES001, (1) RES3025G, (2) RES050, (1) RES3007F, (1) RES3040G, (2) RES003

SUNSET HEALTHCARE SOLUTIONS, INC.

Oxygen administration kit
Primary Device ID00848530106294
NIH Device Record Key64929e83-3c65-4e1c-bfe5-041c9792c236
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespiratory Kit
Version Model NumberRESCON005LK
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 Kittrue
Device Combination Productfalse
Single Usetrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530106294 [Primary]

FDA Product Code

OGLOxygen Administration Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-11
Device Publish Date2025-06-03

On-Brand Devices [Respiratory Kit]

00848530080808This kit contains: 1 CM005M Deluxe Full Face CPAP Mask - Medium, 1 TUB06 Durable CPAP Tubing - 6
00848530080792This kit contains: 1 CM005L Deluxe Full Face CPAP Mask - Large, 1 TUB06 Durable CPAP Tubing - 6f
00848530106294Respiratory Kit - Large 1 kit contains: (4) RES1107, (2) RES012, (1) RES031, (1) RES001, (1) RES

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