FDA UDI
In Commercial Distribution
🇺🇸 United States
CAPIOX
DI: 04987350705693
·
Model: CX*BT05
·
TERUMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CAPIOX
- Primary DI
- 04987350705693
- Version / Model
- CX*BT05
- Company Name
- TERUMO CORPORATION
- Labeler DUNS
- 690543319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4552f84e-48c7-46e6-9f20-dfa9d2a994ca
Device Description
CAPIOX Bubble Trap
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 |
|---|---|---|---|---|
| KRL | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4205 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31711 | Cardiopulmonary bypass system defoamer | A sterile device that is used remove gas bubbles from the blood during cardiopulmonary bypass surgery and is used in conjunction with an oxygenator [the device used to add the necessary oxygen (O2) to the blood before being returned back to the patient]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 54987350705698 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04987350705693 | GS1 |
Customer Contacts
- Phone
- +1(800)521-2818
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Priming Volume 50 Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile. Keep away from sunlight. This way up
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 40 Degrees Celsius