DEVICE: McKesson (20612479187911)

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If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

McKesson
102-SN1C31516P
In Commercial Distribution

MCKESSON MEDICAL-SURGICAL INC.
20612479187911
GS1

10
023904428 *Terms of Use
Insulin SYRINGE 1CC 31GX5/16”
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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?
62003 Intravenous insulin syringe
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for the intravenous (IV) administration of insulin via an IV line or needle. It is typically made of plastic and silicone materials and, if used with a needle, includes a mechanism enabling full retraction of the needle into the barrel to prevent needle sticks, rendering the device unusable; the needle is not included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151949 000
K993017 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
No Device Sizes
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Device Record Status

a71c1c5c-585f-4454-b03f-b5b3858debbb
March 11, 2024
3
December 09, 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
30612479187925 10 20612479187911 In Commercial Distribution Box
40612479187939 5 30612479187925 In Commercial Distribution Case
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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: 10612479218236 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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