FDA UDI In Commercial Distribution 🇺🇸 United States

MedSource Portable O2 System Level 1

DI: 00816703029428 · Model: MS-28250-1 · MEDSOURCE INTERNATIONAL LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MedSource Portable O2 System Level 1
Primary DI
00816703029428
Version / Model
MS-28250-1
Catalog Number
Not Applicable
Company Name
MEDSOURCE INTERNATIONAL LLC
Labeler DUNS
041674552
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-08-03
Public Version
2
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
ec912049-8f3e-4db3-861c-23b964d48161

Device Description

Portable O2 System Level 1

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
60856 Oxygen administration kit

Identifiers

Type ID
Primary 00816703029428