DEVICE: RedDrop Dx (00860011954002)

Device Identifier (DI) Information

RedDrop Dx
300-25-007
In Commercial Distribution

REDDROP DX, INC.
00860011954002
GS1

1
111267004 *Terms of Use
The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
61578 Manual blood lancing device, single-use
A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K234081 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0ec3a726-7913-4c72-b4f2-b90732b73b2e
July 31, 2024
1
July 23, 2024
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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
00860011954033 50 00860011954002 In Commercial Distribution
00860011954026 84 00860011954002 In Commercial Distribution
00860011954019 10 00860011954002 In Commercial Distribution
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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

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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