FDA.reportPublic FDA data

OneTouch Delica Plus Lancet

Primary DI
00812608030033
Brand
OneTouch Delica Plus Lancet
Company
ASAHI POLYSLIDER COMPANY,LIMITED
Model
013-026
Catalog number
OTDP Lancet Bag 33g US/CA
Device description
Bag of 10 sterile lancets 33 Gauge
Published
2022-01-31
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
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
20812608030037PackageGS11000In Commercial Distribution
00812608030033PrimaryGS10
00812608030149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081260803003720812608030037
00812608030033008126080300338126080300330812608030033
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

Contacts#

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

Regulatory Flags#

DUNS number
718296825
Device count
10
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
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
00812608030019OneTouch Delica Plus Lancet02400801OTDP Lancet 33g 100 US2019-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00860015786838True IntegralTRUE INTEGRAL INCQRK2026-05-20
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
00860015383969True IntegralTRUE INTEGRAL INCQRK2026-04-14
00682607541072On Call Lancets (33G)Acon Laboratories, Inc.QRK2026-03-30
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
00197344174433CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
00850080988107AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00682607541058On Call Lancets 30GAcon Laboratories, Inc.QRK2026-02-19
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00810079240609Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRK2026-02-06
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRK2025-12-24
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17