FDA.reportPublic FDA data

OneTouch Delica Plus Lancing Device

Primary DI
00812608030057
Brand
OneTouch Delica Plus Lancing Device
Company
ASAHI POLYSLIDER COMPANY,LIMITED
Model
02397301
Catalog number
OTDP Lancing Device US
Device description
Box of 1 Lancing Device and 10 Sterile Lancets 30 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, 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
20812608030051PackageGS124In Commercial Distribution
00812608030057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081260803005120812608030051
00812608030057008126080300578126080300570812608030057

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, reusableA hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge30Gauge

Contacts#

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

Regulatory Flags#

DUNS number
718296825
Device count
1
Kit
true
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
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
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
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
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
MHC1708001Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1730101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
16945630139311STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
16945630139328STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20