FDA.reportPublic FDA data

Nipro Twist Lancet

Primary DI
00383790011655
Brand
Nipro Twist Lancet
Company
NIPRO MEDICAL CORPORATION
Model
DK-LANCET30100
Device description
Disposable Sterile Lancets - 30G
Published
2023-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383790011662PackageGS1200In Commercial Distribution
00383790011655PrimaryGS10
00383790011648Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383790011662003837900116623837900116620383790011662
00383790011655003837900116553837900116550383790011655
00383790011648003837900116483837900116480383790011648

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The products should be stored in a well-ventilated room and kept away from light, moisture and corrosive gases.

Regulatory Flags#

DUNS number
797372554
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383790011839PRESSONETRG001-000-000-0012026-05-01
00383790012478relasyringe SYPR-03GA-WPSYPR-03GA-WP6; SYPR-03GA-WP602026-05-01
00383790012515relasyringe SYPR-03GA-WP-S-USSYPR-03GA-WP6-S-US; SYPR-03GA-WP60-S-US2026-05-01
00383790008037Nipro SafeTouch NeedleSAH+1825-1M2026-04-30
00383790008105Nipro SafeTouch NeedleSAH+2138-1M2026-04-30
00383790008136Nipro SafeTouch NeedleSAH+2238-1M2026-04-30
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
40383790012377Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
40383790012384Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
40383790012391Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
40383790012407Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
40383790012414Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
00383790004503NIPRO TP-SURETPSURE+12015-09-16
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A226Y/V813-NIJ2025-06-01
00383790011884NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A217Y/V806-NIJ2025-06-01
00383790011891NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A209Y/V803-NIJ2025-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194631000079Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-09
00194631000024Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000031Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000048Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000062Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
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.QRK2025-09-17
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
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