Rubber Suction Elbow Connectors RES028

GUDID 00848530061272

Rubber Suction Elbow Connectors (6/pack)

SUNSET HEALTHCARE SOLUTIONS, INC.

Low-pressure tubing connector, reusable
Primary Device ID00848530061272
NIH Device Record Keyfe54e55f-789d-49b4-bc2d-2fa57f4675d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRubber Suction Elbow Connectors
Version Model NumberRES028
Catalog NumberRES028
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count6
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530061272 [Primary]
GS110848530061279 [Unit of Use]

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-31
Device Publish Date2018-07-31

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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
00848530108298 - CPAP Filter2026-02-04 Filter, USA, Standard S9, AirSense 10, AirCurve, 2/pack
00848530107932 - Nebulizer and Compressor2026-02-03 Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit
10848530108127 - Regulator2026-02-03 Standard CGA 870 Regulator, 1-DISS, 0-25LPM
00848530108137 - CPAP Filter2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack

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