DEVICE: PORTA-WARM (00630140017493)

Device Identifier (DI) Information

PORTA-WARM
11475-010
In Commercial Distribution
11475-010
Cardinal Health 200, LLC
00630140017493
GS1
December 31, 2025
1
961027315 *Terms of Use
INFANT TRANSPORT MATTRESS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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?
46248 Reactive-gel heating pad
An underlay intended to produce heat through chemical reaction typically used to warm and/or maintain the body temperature of neonates or infants. It is typically designed with a soft outer casing (e.g., a soft plastic) that contains a chemically-reactive gel activated by the user (e.g., by breaking its inner enclosure) to provide a heat of approximately normal body temperature (e.g., 38? Celsius) for a limited period. This device is typically used to maintain the body temperature of infant patients during transportation and may be x-ray translucent and magnetic resonance imaging (MRI) compatible. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IMD PACK, HOT OR COLD, DISPOSABLE
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FDA Premarket Submission

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

Sterilization

No
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

10d89ca6-8783-421b-aeda-9ee1fc78893a
July 10, 2023
3
May 30, 2019
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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
50630140017498 1 00630140017493 2025-12-30 In Commercial Distribution CASE
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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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