DEVICE: HemaPrompt (00693501000220)

Device Identifier (DI) Information

HemaPrompt
HP
In Commercial Distribution

AERSCHER, INC
00693501000220
GS1

50
926911454 *Terms of Use
HemaPrompt fecal occult blood test
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Device Characteristics

MR Safe
No
No
Yes
No
No
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?
54533 Faecal occult blood IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KHE Reagent, Occult Blood
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K905782 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 24 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

98f7ef55-a60c-490f-8da1-797d9f3a55ee
July 06, 2018
3
August 22, 2016
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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
No Package DIs found
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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: 00069350100022 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
410-778-2957
wanda@hemprompt.com
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