FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOTRANS™ Pressure Monitoring Kits
DI: 08888893311203
·
Model: CCF-QUAD CUSTOM SET-CC91015
·
BIOPTIMAL INTERNATIONAL PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOTRANS™ Pressure Monitoring Kits
- Primary DI
- 08888893311203
- Version / Model
- CCF-QUAD CUSTOM SET-CC91015
- Catalog Number
- 22-000910-15
- Company Name
- BIOPTIMAL INTERNATIONAL PTE. LTD.
- Labeler DUNS
- 595182247
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2020-06-30
- Public Version Status
- Update
- Public Device Record Key
- c53773ed-ae05-4be4-bd5c-5edd38201c79
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | 870.2850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45275 | Invasive blood pressure transducer set | A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 98888893311206 | GS1 | CTN | 9 | In Commercial Distribution | |
| Package | 18888893311200 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 08888893311203 | GS1 |
Customer Contacts
- Phone
- +6562135777
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark cool dry places