FDA UDI
In Commercial Distribution
🇺🇸 United States
CircuCool™ 8005 Pump
DI: 08714729454816
·
Model: M0048005R0
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CircuCool™ 8005 Pump
- Primary DI
- 08714729454816
- Version / Model
- M0048005R0
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e9ccaf85-4772-471f-af46-fed22b6a6acf
Device Description
Model 8005 Pump
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPB | Cardiac ablation percutaneous catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36664 | Basic roller pump | A mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729454816 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980003 | 000 |
| P980003 | 001 |
| P980003 | 002 |
| P980003 | 004 |
| P980003 | 005 |
| P980003 | 007 |
| P980003 | 008 |
| P980003 | 009 |
| P980003 | 010 |
| P980003 | 013 |
| P980003 | 015 |
| P980003 | 016 |
| P980003 | 018 |
| P980003 | 019 |
| P980003 | 021 |
| P980003 | 024 |
| P980003 | 025 |
| P980003 | 027 |
| P980003 | 028 |
| P980003 | 030 |
| P980003 | 031 |
| P980003 | 034 |
| P980003 | 038 |