FDA UDI
In Commercial Distribution
🇺🇸 United States
CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE
DI: 10607567113760
·
Model: 0012-00-1815
·
Datascope Corp.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE
- Primary DI
- 10607567113760
- Version / Model
- 0012-00-1815
- Catalog Number
- 0012-00-1815
- Company Name
- Datascope Corp.
- Labeler DUNS
- 040874329
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-26
- Public Version
- 1
- Public Version Date
- 2024-08-05
- Public Version Status
- New
- Public Device Record Key
- fc069b04-ff19-48fd-8f26-5e209c09c2e6
Device Description
CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | Cardiovascular | 870.3535 | 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 |
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607567113760 | GS1 |