FDA.reportPublic FDA data

AboutTime MPD 23G x1.8mm Safety Lancet

Primary DI
00628465114553
Brand
AboutTime MPD 23G x1.8mm Safety Lancet
Company
Medical Plastic Devices M.P.D. Inc
Model
1
Catalog number
P1455
Device description
23G x 1.8mm MPD Safety Lancet Box of 100 Single use Sterile Safe Needle is fully shielded before and after use Sterilized by gamma irradiation Comfortable High Quality Tri-bevel point with high speed penetration Tri-Bevel tip ensures good blood flow Optimal ergonomic design Convenient Pre-loaded and pressure activated device Less pressure power.
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

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
00628465014556PrimaryGS10
00628465114553Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628465014556006284650145566284650145560628465014556
00628465114553006284651145536284651145530628465114553

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
244897773
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00628465003314MPD LancetThin 23GaP03312020-09-30
00628465003512MPD LancetThin 23GaP03512020-09-30
00628465005318MPD LancetThin 23GaP03312020-09-30
00628465105513MPD LancetThin 23GaP03512020-09-30
00628465003628MPD LancetUltra Thin 26GaP03622020-09-26
00628465103625MPD LancetUltra Thin 26GaP03622020-09-26
00628465003611MPD Lancet Ultra Thin (Box of 100)1P03612020-02-21
00628465103618MPD Lancet Ultra Thin (Box of 100)1P03612020-02-21
00628465014525AboutTime MPD 21Gx 1.8mm Safety Lancet1P14522020-02-25
00628465014556AboutTime MPD 23G x1.8mm Safety Lancet1P14552020-02-25
00628465014563AboutTime MPD 28G x 1.8mm Safety Lancet1P14562020-02-25
00628465014587AboutTime MPD 30Gx1.8mm Safety Lancet1P14582020-02-25
00628465114522AboutTime MPD 21Gx 1.8mm Safety Lancet1P14522020-02-25
00628465114560AboutTime MPD 28G x 1.8mm Safety Lancet1P14562020-02-25
00628465114584AboutTime MPD 30Gx1.8mm Safety Lancet1P14582020-02-25
00628465045215AboutTime 32G x 4mm Pen Neddles12020-02-24
00628465045284AboutTime 30G x 8mm Pen Neddles12020-02-24
00628465145212AboutTime 32G x 4mm Pen Neddles12020-02-24
00628465045253AboutTime 31G x 5mm Pen Needles1P45252020-02-24
00628465145281AboutTime 30G x 8mm Pen Neddles12020-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
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08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20