DEVICE: OneTouch Delica Plus Lancet (00812608030026)

Device Identifier (DI) Information

OneTouch Delica Plus Lancet
02401101
In Commercial Distribution
OTDP Lancet 30g 100 US
ASAHI POLYSLIDER COMPANY,LIMITED
00812608030026
GS1

100
718296825 *Terms of Use
Box of 100 Sterile Lancets 30 Gauge
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
45142 Blood lancing device tip
A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K221546 000
No CLOSE

Sterilization

Yes
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
Needle Gauge: 30 Gauge
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Device Record Status

35a5d71e-fa30-4873-bf0f-3eff7f79abcd
September 28, 2022
2
February 28, 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
20812608030020 24 00812608030026 In Commercial Distribution Cardboard box
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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: 00812608030149 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1 888 567-3003
customerservice@lifescan.com
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