FDA UDI
In Commercial Distribution
🇺🇸 United States
MXP Device
DI: 00886368000353
·
Model: 8-5139
·
Thermogenesis Corp.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MXP Device
- Primary DI
- 00886368000353
- Version / Model
- 8-5139
- Catalog Number
- 8-5139
- Company Name
- Thermogenesis Corp.
- Labeler DUNS
- 080690327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-05
- Public Version
- 5
- Public Version Date
- 2021-01-12
- Public Version Status
- Update
- Public Device Record Key
- 600a6c0a-dd51-4a08-aa5c-d6800272da85
Device Description
Cell separation processing device
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
- Yes
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47153 | Haematological concentrate system preparation kit, bone marrow concentration | A collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886368000353 | GS1 | ||||
| Package | 10886368000350 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 916-858-5100
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 15 deg C to 30 deg C, Keep dry