DEVICE: Rospital Productos Medicos (00812460028612)

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Device Record History
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Device Identifier (DI) Information
Rospital Productos Medicos
IVCT20
In Commercial Distribution

ATLAS MEDICAL PRODUCTS LLC
00812460028612
GS1

1
013112308 *Terms of Use
I.V. CATHETER PEN TYPE 20 G X 1 1/4 100 EA.
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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?
32151 Peripheral vascular intervention infusion catheter
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K142797 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
Device Size Text, specify: I.V. CATHETER PEN TYPE 20 G X 1 1/4 100 EA.
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Device Record Status
46d4f7bf-34df-4c2a-b1e2-5e1e84ed1c2d
June 10, 2022
2
April 02, 2021
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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
10812460028619 100 00812460028612 In Commercial Distribution INNER BOX
20812460028616 20 10812460028619 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: 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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