DEVICE: PRIMED / Caracal (00842942017520)

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Device Record History
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Device Identifier (DI) Information
PRIMED / Caracal
CPS88335U
In Commercial Distribution

priMED Medical Products Inc
00842942017520
GS1

20
253287569 *Terms of Use
PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, Universal
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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?
32170 Professional examination gown, single-use
A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FME Gown, Examination
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in cool, dry, and well ventilated space out of direct sunlight.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0bc45338-9ae9-4b35-aa5b-b1a01f3bf545
December 04, 2025
1
November 26, 2025
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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
10842942017527 6 00842942017520 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: 90842942017523 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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