FDA UDI
In Commercial Distribution
🇺🇸 United States
Bigger Better-Bladder
DI: 00851997007011
·
Model: BBB38
·
CIRCULATORY TECHNOLOGY INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bigger Better-Bladder
- Primary DI
- 00851997007011
- Version / Model
- BBB38
- Catalog Number
- BBB38
- Company Name
- CIRCULATORY TECHNOLOGY INC
- Labeler DUNS
- 786778944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-03
- Public Version
- 4
- Public Version Date
- 2020-01-22
- Public Version Status
- Update
- Public Device Record Key
- 7a4b0063-2d69-4458-9d7e-04c4d2d00bfa
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 31710 | Cardiotomy reservoir | A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851997007011 | GS1 |
Customer Contacts
- Phone
- +1(516)624-2424
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981284 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 0.375 | Inch | |
| Device Size Text, specify | Connects to standard 3/8" perfusion tubing connector |