DEVICE: McKesson (20612479280896)
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If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
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? |
|---|---|---|---|---|
| 63285 | Multi-purpose therapeutic saline solution |
A water-based salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple patient applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care in the home. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FRO | Dressing, Wound, Drug |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K993969 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
bc314da5-f95d-45bf-9e05-9895cdcf64c8
December 10, 2025
1
December 02, 2025
December 10, 2025
1
December 02, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 40612479280906 | 20 | 20612479280896 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
10612479281537
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined