FDA.report

Medline

Primary DI
20197344009357
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPHLANCINGPN2
Catalog number
MPHLANCINGPN2
Device description
ADJUSTABLE LANCING DEVICE, NONSAFETY
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
QRLMultiple use blood lancet for single patient use only

Product Code Classifications

CodeDeviceSpecialtyClass
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344009357PackageGS1100In Commercial Distribution
00197344009353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2019734400935720197344009357
00197344009353001973440093531973440093530197344009353

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
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
true
Sterilization required before use
false

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10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
36945630142001STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
20682607541823On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
50810011730644HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730656HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730663AllevyTianjin Huahong Technology Co., Ltd.QRL2025-12-24
06949517009462N/MShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-12-10
00850065253305LIVE TULA Lancing DeviceTULA HEALTH, INC.QRL2025-12-03
06949517009028One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-09-14
MHC18080020EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-08-04
56949517070894One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
56949517070900One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
56949517070917One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
06949517008878One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
00311917069227WalgreensWALGREEN CO.QRL2025-06-20
00810011730601SinocareTianjin Huahong Technology Co., Ltd.QRL2025-06-19
10673486002478GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRL2025-06-10
26945630136669sutter syncSterilance Medical (Suzhou) Inc.QRL2025-05-23
10673486002461GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRL2025-05-14
30810011730336Care TouchTianjin Huahong Technology Co., Ltd.QRL2025-04-23
50810011730590LinkSunTianjin Huahong Technology Co., Ltd.QRL2025-04-23
36945630136178TRANSTEKSterilance Medical (Suzhou) Inc.QRL2025-04-22
26945630136164TRANSTEKSterilance Medical (Suzhou) Inc.QRL2025-04-22
10875011000120Greater Goods Greater GoodsQRL2025-04-20
00840423500516VivaGuard Lancets (21G)ABOUND Diagnostics, Inc.QRL2025-04-11
00840423500103VivaGuard Lancets (28G)ABOUND Diagnostics, Inc.QRL2025-04-11
00840423500424VivaGuard Lancing Device ABOUND Diagnostics, Inc.QRL2025-04-11
16971292003516AUVONShenzhen Yuwen E-Commerce Co., Ltd.QRL2025-04-10
16971292003523AUVONShenzhen Yuwen E-Commerce Co., Ltd.QRL2025-04-10
16971292003509AUVONShenzhen Yuwen E-Commerce Co., Ltd.QRL2025-04-09