DEVICE: VYGON (03660812123747)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

VYGON
221.050
In Commercial Distribution
221.050
VYGON
03660812123747
GS1

1
392994778 *Terms of Use
Lectroflex - Ø2.5×4.0mm - L.50cm - Vol.2.8ml - Luer-lock Male/Male
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
12170 Intravenous administration tubing extension set
A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

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

291eea73-7c3e-44dc-8108-3d1e54d61d63
July 02, 2020
1
June 24, 2020
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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
53660812123742 12 33660812123748 In Commercial Distribution Case
33660812123748 25 03660812123747 In Commercial Distribution Box
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Secondary DI

[?]
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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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