FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Constavac CBC II
DI: 00855168008135
·
Model: 225-028-516
·
3T MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Constavac CBC II
- Primary DI
- 00855168008135
- Version / Model
- 225-028-516
- Catalog Number
- 225-028-516
- Company Name
- 3T MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 112462671
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-07
- Public Version
- 2
- Public Version Date
- 2022-04-19
- Public Version Status
- Update
- Public Device Record Key
- 74354d6d-2a64-45d9-a33c-285271d9fc81
- Distribution End Date
- 2022-04-18
Device Description
ConstaVac CBCII Blood Conservation Kit with 1/4” Round PVC Drain & Curved Trocar
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
- 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 |
|---|---|---|---|---|
| CAC | Apparatus, Autotransfusion | Anesthesiology | 868.5830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47977 | Whole-blood-recovery autotransfusion system, powered | An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00855168008142 | GS1 | Pack | 6 | Not in Commercial Distribution | 2022-04-18 |
| Primary | 00855168008135 | GS1 |
Customer Contacts
- Phone
- 7345259580
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970714 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.4 Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal