DEVICE: Healqu (00819143020888)

Device Identifier (DI) Information

Healqu
9020901
In Commercial Distribution

Healqu LLC
00819143020888
GS1

1
080712881 *Terms of Use
Healqu Transparent Dressing (23/8 x 23/4)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
58301 Synthetic polymer semi-permeable film dressing, adhesive
A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, Wound, Occlusive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

7263f2c4-0a6b-45fc-b4ae-b0a2f1ee67c2
July 24, 2025
4
November 08, 2023
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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
30819143020889 100 00819143020888 In Commercial Distribution Box
20819143020882 4 30819143020889 In Commercial Distribution Case
00819143024114 20 00819143020888 In Commercial Distribution Box of 20
00819143024121 40 00819143024114 In Commercial Distribution Case of Box of 20
00819143025203 20 00819143020888 In Commercial Distribution US- Box of 20
00819143025210 40 00819143025203 In Commercial Distribution US-Case of Box of 20
00819143025302 100 00819143020888 In Commercial Distribution CA- Box of 100
00819143025319 4 00819143025302 In Commercial Distribution CA- Case of 100 Box
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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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