FDA UDI In Commercial Distribution 🇺🇸 United States

A.M.G. PP Sterile

DI: 08052705496253 · Model: A.M.G. MODULE PP NO T.TP.STER. · EUROSETS SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
A.M.G. PP Sterile
Primary DI
08052705496253
Version / Model
A.M.G. MODULE PP NO T.TP.STER.
Catalog Number
US5400
Company Name
EUROSETS SRL
Labeler DUNS
439962374
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-11
Public Version
2
Public Version Date
2020-10-26
Public Version Status
Update
Public Device Record Key
9d8f96c2-4e18-4b9c-85a7-f628c45c2aae

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DTZ Oxygenator, Cardiopulmonary Bypass

GMDN Terms

Code Name
17643 Extracorporeal membrane oxygenator

Identifiers

Type ID
Package 18052705496250
Primary 08052705496253
Package 28052705496257

Customer Contacts