Performance Home Medical 0836

GUDID 20889483221669

Composite Respiratory Kits, 2 - 16SOFT-4, 2 - 0556B, 1 - 0027B, 1 - 0052B, 1 - No Smoking Sign, 2 - 1220-0

SUNMED, LLC

Oxygen administration kit
Primary Device ID20889483221669
NIH Device Record Keydeeb37d3-46e8-49f8-a1aa-79ee0b1a7025
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerformance Home Medical
Version Model Number0836
Catalog Number0836
Company DUNS069009268
Company NameSUNMED, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078002540 [Previous]
GS110889483221662 [Primary]
GS120889483221669 [Package]
Contains: 10889483221662
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-08
Device Publish Date2025-12-31

Devices Manufactured by SUNMED, LLC

30889483562615 - BALLARD™2026-02-06 BALLARD™ TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Endotracheal
30889483563391 - BALLARD™2026-02-06 BALLARD™ ORAL CARE SUCTION CATHETER FOR ADULTS
30889483563681 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal, WET PAK™
30889483563711 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal, WET PAK™
30889483567030 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Elbow, Endotracheal, WET PAK™
30889483623316 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Tracheostomy, 12 F
30889483623323 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Tracheostomy, 12 F, WET PAK™
30889483623347 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Endotracheal, 12 F

Trademark Results [Performance Home Medical]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERFORMANCE HOME MEDICAL
PERFORMANCE HOME MEDICAL
76333816 2607517 Live/Registered
Performance Modalities, Inc.
2001-11-06
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.