FDA.reportPublic FDA data

medisana

Primary DI
06949517010017
Brand
medisana
Company
Shandong Lianfa Medical Plastic Products CO.,LTD
Model
LF-TL-30
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K222472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222472000Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd.2022-11-30QRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06949517010017PrimaryGS10
56949517070955Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949517010017069495170100176949517010017
5694951707095556949517070955

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Regulatory Flags#

DUNS number
421330121
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06949517010024medisanaLDF2026-07-14
06949517002418Twist Lancet (30G)LF-TL-302019-04-30
06949517090033One +StepLDE2026-04-22
06949517090040One +StepLDE2026-04-22
06949517006201N/MLDC2026-01-31
06949517009462N/MLDC2025-12-10
06949517009028One +StepLDE2025-09-14
06949517008847One +StepLF-TL-23-I2025-06-27
06949517008854One +StepLF-TL-28-I2025-06-27
06949517008861One +StepLF-TL-30-II2025-06-27
56949517070894One +StepLF-TL-23-I2025-06-27
56949517070900One +StepLF-TL-28-I2025-06-27
56949517070917One +StepLF-TL-30-II2025-06-27
06949517008878One +StepLDE2025-06-27
06949517008021Twist Lancet(30G)LF-TL-302024-11-01
56949517070887Twist Lancet(30G)LF-TL-302024-11-01
06949517007024N/MLDF2024-05-28
06949517004313Twist Lancet(30G)LF-TL-302020-10-16
06949517004320Twist Lancet(30G)LF-TL-302020-10-16
06949517004337Twist LancetLF-TL-302020-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06949517010024medisanaShandong Lianfa Medical Plastic Products CO.,LTDQRK2026-07-14
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
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
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