Replacement Part

GUDID 00848530107611

Respironics Everflo SMC Pilot and Body Valve (OEM: 1111248/1111249)

SUNSET HEALTHCARE SOLUTIONS, INC.

Tracheal pilot tube repair kit
Primary Device ID00848530107611
NIH Device Record Key5865c055-acb0-49a8-a9b0-c38d8756b55b
Commercial Distribution StatusIn Commercial Distribution
Brand NameReplacement Part
Version Model NumberRP082
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530107611 [Primary]

FDA Product Code

BYXTubing, Pressure And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-20
Device Publish Date2025-11-12

On-Brand Devices [Replacement Part]

10848530107625LUISA, Astral, V*Home, and Trilogy O2 Quick Connect Straight Adapter, 1/4" Barb - 2/PK
00848530107611Respironics Everflo SMC Pilot and Body Valve (OEM: 1111248/1111249)

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