FDA UDI
In Commercial Distribution
🇺🇸 United States
Global Blood Resources
DI: 00854438002002
·
Model: HBBSD2000
·
GLOBAL BLOOD RESOURCES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Global Blood Resources
- Primary DI
- 00854438002002
- Version / Model
- HBBSD2000
- Company Name
- GLOBAL BLOOD RESOURCES LLC
- Labeler DUNS
- 095980509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- d48727a7-2b83-4e3a-bd23-d23e5b0b7d9c
Device Description
Blood Reservoir
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | Cardiovascular | 870.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34863 | Red blood cell-recovery autotransfusion system | An assembly of devices designed to collect and process blood lost by a patient to obtain red blood cells for subsequent reinfusion into the same patient (i.e., autotransfusion). It typically includes a disposable suction system to collect blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., a centrifuge) to separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate microfilters, and a reinfusion bag that stores the red blood cells in saline. The system is used mainly during surgical procedures to minimize allogeneic blood use, but may be used postoperatively and in emergency or intensive care units. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854438002002 | GS1 | ||||
| Package | 10854438002009 | GS1 | Carton | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 919-570-9605
- [email protected]