FDA.reportPublic FDA data

Angel Processing Sets (NA)

Primary DI
10852714003016
Brand
Angel Processing Sets (NA)
Company
NUO THERAPEUTICS INC
Model
976000501
Device description
Angel Processing Sets (NA) Case of 8 Kits or 8 Trays with 020201 Case Label Processing Set (NA)
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852714003016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085271400301610852714003016

GMDN Terms#

Term, Definition table
TermDefinition
Blood washing/centrifugation bagA flexible container intended to be used to facilitate blood processing via blood washing and/or centrifugation (e.g., cryoprecipitation) to achieve separation of blood components [e.g., red blood cells (RBCs), platelets, plasma], typically to generate a blood product from autologous or donor blood for procedural (e.g., surgical haemostasis) or transfusion applications [e.g., fibrinogen rich cryoprecipitate]. It is additionally intended to be used as a blood storage bag, and is made of flexible durable materials that withstand centrifugation and freezing/thawing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
132418851
Device count
1
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
10852714003023Angel Processing Sets (EU)9760006012016-09-19
00852714003019Angel Processing Sets (NA)9760005012016-09-19
00852714003026Angel Processing Sets (EU)9760006012016-09-19
10852714003009ActivAT9661500002016-08-09
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

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00850083564056GoldrushBahia Medical Inc.ORG2026-04-03
00850083564063GenesisBahia Medical Inc.ORG2026-04-03
00850023741561CERVOS PLATELET SEPARATOR 80 KITRANFAC CORP.ORG2026-03-30
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00850075308101CER-PRP-160 KitRANFAC CORP.ORG2026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILERANFAC CORP.ORG2026-03-30
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08809410200046Dr.PRPRmedica Co.,LtdORG2026-02-02
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
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M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
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