DEVICE: TRUWAVE (07460691957640)
Device Identifier (DI) Information
TRUWAVE
MK2458
In Commercial Distribution
MK2458
Edwards Lifesciences LLC
MK2458
In Commercial Distribution
MK2458
Edwards Lifesciences LLC
4 PORT CONNECTOR STERILE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Intravenous line/syringe Luer connector, sterile | A sterile device intended to be used to assemble an intravenous (IV) fluid line by connecting tubing, stopcocks, adaptors/connectors, and syringes to the IV line; it may also be used to connect a syringe to a vial adaptor. It has a Luer connection (slip or lock) at each end and may incorporate features to prevent leakage (drip-lock), egress, and ingress of materials (i.e., hazardous drugs, microbes) or minimize the potential of aerosolization; it does not contain a valve mechanism or closed pressure equalization chamber. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXO | TRANSDUCER, PRESSURE, CATHETER TIP |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142749 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
311998ff-2600-493d-9abf-e6170843a28a
July 06, 2018
3
September 03, 2016
July 06, 2018
3
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 |
---|---|---|---|---|---|
57460691957645 | 50 | 07460691957640 | 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