DEVICE: RedDrop Dx (00860011954002)
Device Identifier (DI) Information
RedDrop Dx
300-25-007
In Commercial Distribution
REDDROP DX, INC.
300-25-007
In Commercial Distribution
REDDROP DX, INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K234081 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0ec3a726-7913-4c72-b4f2-b90732b73b2e
July 31, 2024
1
July 23, 2024
July 31, 2024
1
July 23, 2024
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined