FDA UDI
In Commercial Distribution
🇺🇸 United States
CAPIOX® SP PUMP
DI: 04987350706119
·
Model: CX*SP45
·
TERUMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CAPIOX® SP PUMP
- Primary DI
- 04987350706119
- Version / Model
- CX*SP45
- Company Name
- TERUMO CORPORATION
- Labeler DUNS
- 690543319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 858a5bb5-26e9-4456-854c-41152426110f
Device Description
CAPIOX® SP PUMP
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 |
|---|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Cardiovascular | 870.4360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36379 | Centrifugal circulatory assist pump, electric | A mains electricity (AC-powered), specially constructed, centrifugal pump that is used to maintain blood circulation in heart failure. It is used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function. This dependence will be due to the lack of the heart's ability to function normally. The pump may be used during open heart surgery and postoperatively for a short period to assist the heart in regaining function. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987350706119 | GS1 | ||||
| Package | 54987350706114 | GS1 | 10 Piece Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-521-2818
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 40 Degrees Celsius