Tracheostomy and Suction Accessory

GUDID 10848530106215

Adult 72hr Closed Suction Catheter Endotracheal - 12 FR 530mm

SUNSET HEALTHCARE SOLUTIONS, INC.

Closed-suction breathing circuit connector/switch
Primary Device ID10848530106215
NIH Device Record Keyc4627112-3446-4960-81fb-721573b79183
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracheostomy and Suction Accessory
Version Model NumberVEN77253012M
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
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
GS100848530106218 [Primary]
GS110848530106215 [Package]
Contains: 00848530106218
Package: [10 Units]
In Commercial Distribution
GS120848530106212 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 [Tracheostomy and Suction Accessory]

00848530099640Suction Canister Disposable 1200CC - 48/Case
10848530106277Adult 72hr Closed Suction Catheter Tracheostomy - 16Fr 305mm
10848530106260Adult 72hr Closed Suction Catheter Tracheostomy - 14Fr 305mm
10848530106253Adult 72hr Closed Suction Catheter Tracheostomy - 12Fr 305mm
10848530106246Adult 72hr Closed Suction Catheter Tracheostomy - 10Fr 305mm
10848530106239Adult 72hr Closed Suction Catheter Endotracheal - 16FR 530mm
10848530106222Adult 72hr Closed Suction Catheter Endotracheal - 14FR 530mm
10848530106215Adult 72hr Closed Suction Catheter Endotracheal - 12 FR 530mm
20848530106205Adutl 72 hr Closed Suction Catheter Endotracheal - 10Fr 530mm
00848530105860Endotracheal Tube Holder - Pediatric
10848530105850Endotracheal Tube Holder - Adult - 10/case
00848530105846Endotracheal Tube Holder Pediatric - Bulk - 1000pcs
00848530105839Endotracheal Tube Holder Adult - 1000pcs - BULK
00848530104474Pediatric Flexible Connector - 50/case
10848530095229Deluxe Closed Suction System For Adult Tracheostomy with MDI Port - Size 16 FR

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