FDA.reportPublic FDA data

OneTouch Delica Plus Lancet

Primary DI
00812608030019
Brand
OneTouch Delica Plus Lancet
Company
ASAHI POLYSLIDER COMPANY,LIMITED
Model
02400801
Catalog number
OTDP Lancet 33g 100 US
Device description
Box of 100 Sterile Lancets 33 Gauge
Published
2019-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20812608030013PackageGS124In Commercial Distribution
00812608030019PrimaryGS10
00812608030149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081260803001320812608030013
00812608030019008126080300198126080300190812608030019
00812608030149008126080301498126080301490812608030149

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 Gauge33Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 888 567-3003customerservice@lifescan.com

Regulatory Flags#

DUNS number
718296825
Device count
100
Lot or batch
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196395811MEDLINEMEDLINE INDUSTRIES, INC.QRK2026-07-22
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00810011730748HuahongTianjin Huahong Technology Co., Ltd.FMK2026-07-10
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00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810178887750Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00810178887767Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
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08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
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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
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