DEVICE: Swabable Vial Adapter with Vented Spike (07290108240023)

Device Identifier (DI) Information

Swabable Vial Adapter with Vented Spike
8073012
In Commercial Distribution

MEDIMOP MEDICAL PROJECTS LTD.
07290108240023
GS1

1
600267793 *Terms of Use
Swabable Vial Adapter 20mm with Vented Spike – VF
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Medication transfer needle, filtered/vented A sterile, sharply-pointed, dual-lumen plastic tube intended to be used to transfer medication from a vial to another container during medication preparation (e.g., in the pharmacy). It is designed to simultaneously aspirate medication and allow air into the vial to reduce back pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LHI Set, I.V. Fluid Transfer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K072511 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bf319cd3-492f-493a-bcc1-b772ca257554
July 06, 2018
3
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
27290108240027 4 17290108240020 In Commercial Distribution
17290108240020 145 07290108240023 In Commercial Distribution
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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