Cough Assist Kit

GUDID 00848530095017

(1) RES013, (1) BF2200, (1) TUB06 - Cough Assist Kit Respironics OEM#1090835

SUNSET HEALTHCARE SOLUTIONS, INC.

Respirator filter/cartridge, particulates
Primary Device ID00848530095017
NIH Device Record Key7dd409e5-91dd-4a35-b327-f4694e784087
Commercial Distribution StatusIn Commercial Distribution
Brand NameCough Assist Kit
Version Model NumberCAKIT001
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530095017 [Primary]

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-05-31

On-Brand Devices [Cough Assist Kit]

00848530101855(1) RES013, (1) BF2200, (1) TUB06 - Cough Assist Kit Respironics OEM#1090835 *PRIVATE LABELED*
00848530098407(1) RES013, (1) BF2200, (1) TUB06 (1) RES019 - Cough Assist Kit OEM#10836-504
00848530095017(1) RES013, (1) BF2200, (1) TUB06 - Cough Assist Kit Respironics OEM#1090835
00848530105440Cough Assist Kit - This kit contains: (1) RES013, (1) BF2200, (1) TUB004
00848530093839Trach Kit 1 kit contains: RES014 (1 each), BF2200 (1 each), TUB06 (1 each)

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