FDA UDI In Commercial Distribution 🇺🇸 United States

O2 Starter Kit

DI: 00848530084301 · Model: APRO025RESO2KIT · SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
O2 Starter Kit
Primary DI
00848530084301
Version / Model
APRO025RESO2KIT
Catalog Number
APRO025RESO2KIT
Company Name
SUNSET HEALTHCARE SOLUTIONS, INC.
Labeler DUNS
141668116
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-07-31
Public Version
2
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
ce384c26-f141-41c8-bd46-ac791740d99a

Device Description

This kit contains: 1 RES032 Cylinder Wrench, 1 RES012 Tubing Connector, 1 RES018 Tubing Connector with Swivel, 1 RES035 Brass Washer with Rubber Ring, 2 RES003 Oxygen In Use Sign, 2 RES1107 Adult Oxygen Cannula with 7ft Tubing.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
60856 Oxygen administration kit

Identifiers

Type ID
Primary 00848530084301

Customer Contacts

Phone
877-578-6738