DEVICE: RELI® (00386120008660)

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Device Record History
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Device Identifier (DI) Information
RELI®
GSIS21G-7
In Commercial Distribution
GSIS21G-7
MYCO MEDICAL SUPPLIES INC.
00386120008660
GS1

1
879187821 *Terms of Use
Reli Gem Safety Infusion Set 21G x 3/4", 7" tubing
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
58497 Blood collection set, invasive
A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, Administration, Intravascular
FMI Needle, Hypodermic, Single Lumen
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K170276 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 21 Gauge
Device Size Text, specify: 7" tubing
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Device Record Status
95527492-bfd4-4c18-990b-449c7e46f645
April 07, 2021
2
October 26, 2018
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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
20386120008664 9 10386120008667 In Commercial Distribution Case
10386120008667 100 00386120008660 In Commercial Distribution Inner Carton
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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