FDA UDI In Commercial Distribution 🇺🇸 United States

ActivAT

DI: 00852714003002 · Model: 966150000 · NUO THERAPEUTICS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ActivAT
Primary DI
00852714003002
Version / Model
966150000
Company Name
NUO THERAPEUTICS INC
Labeler DUNS
132418851
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-09
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
eaa797f5-e0fc-47bc-b75f-3b7b3b7f7802

Device Description

ActivAT Single Unit (Kit or Tray) with 966155001 ActivAT Tray Label

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
44903 Blood transfer set

Identifiers

Type ID
Primary 00852714003002