DEVICE: REMEL (00848838065835)

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Device Record History
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Device Identifier (DI) Information
REMEL
R40132
In Commercial Distribution
R40132
REMEL, INC.
00848838065835
GS1

1
065769564 *Terms of Use
Ethanol (90%) MeOH (4.5%) IPA (5.5%) BTL/250ml
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
43584 Acid-alcohol solution IVD
An acid-alcohol solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PPM General Purpose Reagent
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
73ab1b65-3d38-448d-adc7-13f2bfe4e7fb
January 12, 2023
1
January 04, 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
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: 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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