FDA.reportPublic FDA data

OneTouch Delica Plus Lancet

Primary DI
00812608030156
Brand
OneTouch Delica Plus Lancet
Company
ASAHI POLYSLIDER COMPANY,LIMITED
Model
013-027
Catalog number
OTDP Lancet Bag 30g US/CA
Device description
Bag of 10 sterile lancets 30 Gauge
Published
2021-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221546000OneTouch Delica Plus Lancing SystemAsahi Polyslider Co., Ltd.2022-08-23QRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20812608030044PackageGS11000In Commercial Distribution
00812608030040PrimaryGS10
00812608030156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081260803004420812608030044
00812608030040008126080300408126080300400812608030040
00812608030156008126080301568126080301560812608030156

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge30Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 888 597-3003customerservice@lifescan.com

Regulatory Flags#

DUNS number
718296825
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30389701009194CAPIJECT SAFETY LANCET2001012023-08-01
30389701009200CAPIJECT SAFETY LANCET2001022023-08-01
30389701009217CAPIJECT SAFETY LANCET2001032023-08-01
30389701009224CAPIJECT SAFETY LANCET2001042023-08-01
30389701009231CAPIJECT SAFETY LANCET2001052023-08-01
80812608030275CAPIJECT SAFETY LANCET2001012023-08-01
50389701009204CAPIJECT SAFETY LANCET2001022023-08-01
50389701009211CAPIJECT SAFETY LANCET2001032023-08-01
50389701009228CAPIJECT SAFETY LANCET2001042023-08-01
50389701009235CAPIJECT SAFETY LANCET2001052023-08-01
04580505780462HemoCue Safety Lancet1301482022-11-30
84580505780659HemoCue Safety Lancet1301482022-11-30
00812608030262OneTouch Delica Safety024-318OTD Safety 30g US 2002022-11-25
20812608030266OneTouch Delica Safety024-318OTD Safety 30g US 2002022-11-25
00812608030026OneTouch Delica Plus Lancet02401101OTDP Lancet 30g 100 US2019-02-28
00812608030033OneTouch Delica Plus Lancet013-026OTDP Lancet Bag 33g US/CA2022-01-31
00812608030040OneTouch Delica Plus Lancet013-027OTDP Lancet Bag 30g US/CA2021-12-06
00812608030057OneTouch Delica Plus Lancing Device02397301OTDP Lancing Device US2019-02-28
00812608030217OneTouch Delica Plus Lancet02419901OTDP Lancet 30g 30 US2020-11-18
00812608030149OneTouch Delica Plus Lancet02419901OTDP Lancet 30g 30 US2020-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20