FDA.reportPublic FDA data

ActivAT

Primary DI
10852714003009
Brand
ActivAT
Company
NUO THERAPEUTICS INC
Model
966150000
Device description
ActivAT Case of 8 Kits or 8 Trays with 966155500 ActivAT Outer Carton Label
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852714003009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085271400300910852714003009

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.

Regulatory Flags#

DUNS number
132418851
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852714003016Angel Processing Sets (NA)9760005012016-09-19
10852714003023Angel Processing Sets (EU)9760006012016-09-19
00852714003019Angel Processing Sets (NA)9760005012016-09-19
00852714003026Angel Processing Sets (EU)9760006012016-09-19
10852714003030Angel Blood Access Kits (NA)9760005022016-09-19
00852714003002ActivAT9661500002016-08-09
00852714003033Angel Blood Access Kits9760005022016-09-19
00852714003057Angel Whole Blood Processing System9760001002016-09-19
00852714003064Angel Whole Blood Processing System9760009002016-09-19
00852714003071Angel Whole Blood Processing System9760001012016-09-19
00852714003088Angel Whole Blood Processing System Machine - EU - Reworked9760009012016-09-19