FDA.reportPublic FDA data

Mckesson

Primary DI
40612479126372
Brand
Mckesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
06-005
Device description
DEVICE, LANCET (36/CS)
Published
2020-08-04
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
false

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479126372PackageGS136In Commercial Distribution
20612479126347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247912637240612479126372
2061247912634720612479126347

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
false
Expiration date on label
false
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
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
26931918108718AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
36945630141981STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
06945630141997STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
30885632507070MedichoiceOWENS & MINOR DISTRIBUTION, INC.FMK2026-02-17
00843484108356Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
00843484108370Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
10848530107557DiabeticsSUNSET HEALTHCARE SOLUTIONS, INC.FMK2025-12-19
04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
01850011833123VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833192VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833215VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833222VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833284VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833291VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833307VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833314VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833338VerifinePromisemed Medical Devices Inc.FMK2025-11-20
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01850011833376VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833383VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833390VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833406VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833413VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833451VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833468VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833512VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833819VerifinePromisemed Medical Devices Inc.FMK2025-11-20