FDA.reportPublic FDA data

Medline

Primary DI
20193489006428
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPHSFTY21
Catalog number
MPHSFTY21
Device description
LANCET,SAFETY,21G,1.8MM,PUSH BUTTON
Published
2022-12-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKSingle use only blood lancet with an integral sharps injury prevention feature

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
20193489006428PackageGS118In Commercial Distribution
00193489006424PrimaryGS10
10193489006421Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019348900642820193489006428
00193489006424001934890064241934890064240193489006424
1019348900642110193489006421

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
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 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
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01850011833338VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833352VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833369VerifinePromisemed Medical Devices Inc.FMK2025-11-20
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