DEVICE: Aero-Med (10885380175848)

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Device Record History
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Device Identifier (DI) Information
Aero-Med
CA25575
Not in Commercial Distribution
CA25575
AERO-MED, LLC
10885380175848
GS1
May 31, 2025
1
194550042 *Terms of Use
hCG Combo Specialty Bar Code Label Collection Kit, IU Health Only
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
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?
66852 Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to detect pregnancy.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OIB Blood and urine collection kit (excludes HIV testing)
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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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
5f0a906e-e0de-4126-a931-e4c68b7528f7
June 02, 2025
5
November 06, 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
50885380175846 40 20885380175845 2025-05-31 Not in Commercial Distribution CASE
20885380175845 30 10885380175848 2025-05-31 Not in Commercial Distribution KIT
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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