FDA UDI
In Commercial Distribution
🇺🇸 United States
Celling ART BMC
DI: 00817771028795
·
Model: 0886-0001
·
Celling Biosciences
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Celling ART BMC
- Primary DI
- 00817771028795
- Version / Model
- 0886-0001
- Catalog Number
- 0886-0001
- Company Name
- Celling Biosciences
- Labeler DUNS
- 021560394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-11
- Public Version
- 1
- Public Version Date
- 2025-04-21
- Public Version Status
- New
- Public Device Record Key
- c41e5a53-442e-4a78-a242-9b3df1febf06
Device Description
ART BMC Processing Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 | 00817771028795 | GS1 |
Customer Contacts
- Phone
- 512-637-6745
- [email protected]