Drainage Bag w/Y Adapter & Hanger RES071

GUDID 10848530060777

Drainage Bag w/Y Adapter & Hanger

SUNSET HEALTHCARE SOLUTIONS, INC.

Breathing circuit condensate trap, single-use
Primary Device ID10848530060777
NIH Device Record Key1ab3e74d-2640-4365-ba54-8fa4846e56cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrainage Bag w/Y Adapter & Hanger
Version Model NumberRES071
Catalog NumberRES071
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530060770 [Primary]
GS110848530060777 [Package]
Contains: 00848530060770
Package: [50 Units]
In Commercial Distribution

FDA Product Code

BYHDrain, Tee (Water Trap)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530108434 - Oxygen Kit2026-02-26 Oxygen Kit (6- RES1107S, 1- RES3050G,2- RES012, 2 -RES001)
00848530108311 - Oxygen Kit2026-02-19 10L Oxygen Supply Kit 4 RES1107SHF High Flow Soft Cannula with 7ft Supply Tube 2 RES003 No Smoking Sign 2 RES3025G Oxygen Suppl
00848530108335 - Repair Parts2026-02-19 CAIRE Contents Gauge Tubing (OEM# B-775856-SV) - 2/PK
00848530108342 - Repair Parts2026-02-19 C1000/C1000T Portable Rubber Foot - 56/Sheet - 10 Sheet/Case - (OEM# B-775010-00)
00848530108168 - Regulators2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM
10848530108172 - CPAP Accessory2026-02-10 Sunset Nasal Gel Pad - 5/PK
00848530108267 - Filter - Vent2026-02-10 Luisa Gross Particle Internal Filter - 1/PK
10848530108271 - CPAP Tubing2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.