FDA UDI
In Commercial Distribution
🇺🇸 United States
Angel Processing Sets (NA)
DI: 10852714003016
·
Model: 976000501
·
NUO THERAPEUTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Angel Processing Sets (NA)
- Primary DI
- 10852714003016
- Version / Model
- 976000501
- Company Name
- NUO THERAPEUTICS INC
- Labeler DUNS
- 132418851
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- 09968fa6-c372-43ea-91ab-4991ddcf788e
Device Description
Angel Processing Sets (NA) Case of 8 Kits or 8 Trays with 020201 Case Label Processing Set (NA)
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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16752 | Blood washing/centrifugation bag | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10852714003016 | GS1 |