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
02401101
In Commercial Distribution
OTDP Lancet 30g 100 US
ASAHI POLYSLIDER COMPANY,LIMITED
Box of 100 Sterile Lancets 30 Gauge
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K221546 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Needle Gauge: 30 Gauge |
Device Record Status
35a5d71e-fa30-4873-bf0f-3eff7f79abcd
September 28, 2022
2
February 28, 2019
September 28, 2022
2
February 28, 2019
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00812608030149
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 888 567-3003
customerservice@lifescan.com
customerservice@lifescan.com