DEVICE: TRUWAVE, VAMP PLUS (07460691950498)
Device Identifier (DI) Information
TRUWAVE, VAMP PLUS
PXVP1066
In Commercial Distribution
PXVP1066
Edwards Lifesciences LLC
PXVP1066
In Commercial Distribution
PXVP1066
Edwards Lifesciences LLC
PRESSURE MONITORING SET
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Arterial blood sampling kit | A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device. |
Blood pressure transducer, single-use | A sterile, noninvasive electronic device intended to convert pressure into electrical signals for the invasive measurement of blood pressure. It is a small housing intended to be connected to invasive vascular access device(s) [e.g., needle, catheter] and will either include a display or be intended to be connected to an independent patient monitoring system; it may include a guidewire access port. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXO | TRANSDUCER, PRESSURE, CATHETER TIP |
KRA | Catheter, continuous flush |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE. |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 3 Milliliter |
Device Record Status
98805b5f-1f48-45cb-b8b1-79576dc86a14
March 29, 2018
2
September 03, 2016
March 29, 2018
2
September 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
57460691950493 | 10 | 07460691950498 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)822-9637
tech_support@edwards.com
tech_support@edwards.com