DEVICE: TRUWAVE (07460691951990)

Device Identifier (DI) Information

TRUWAVE
50P200R
In Commercial Distribution
50P200R
Edwards Lifesciences LLC
07460691951990
GS1

1
134139174 *Terms of Use
MALE/MALE LUER LOCK ADAPTOR WITH ROTATING NUT
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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.
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FDA Product Code

[?]
Product Code Product Code Name
DXO TRANSDUCER, PRESSURE, CATHETER TIP
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142749 000
K171996 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2c412683-e715-4294-a18d-cb0a9c974425
July 06, 2018
3
September 03, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
57460691951995 50 07460691951990 In Commercial Distribution Shipper
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
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