FDA.reportPublic FDA data

UltraCare Blood Lancets

Primary DI
00372217002017
Brand
UltraCare Blood Lancets
Company
ARISE MEDICAL LLC
Model
240410
Device description
UltraCare Blood Lancets - 100 Count
Published
2018-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00372217002017PrimaryGS10
00372217002512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00372217002017003722170020173722170020170372217002017
00372217002512003722170025123722170025120372217002512

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

Regulatory Flags#

DUNS number
081149273
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00372217003014ProCare IR Thermometer2403902018-10-01
00372217037019Procare Tens Machine2404982019-06-27
00372217036081Safecare Vinyl Exam Gloves2404952023-02-08
00372217036098Safecare Vinyl Exam Gloves2404962023-02-08
00372217036104Safecare Vinyl Exam Gloves2404972023-02-08
00372217036319Safecare Vinyl Exam Gloves2404932023-02-08
00372217036326Safecare Vinyl Exam Gloves2404942023-02-08
00372217003021Procare Forehead Infrared Thermometer240540PG-IRT16022020-07-13
00372217005094Safari Express Pediatric Nebulizer2405382020-08-22
00372217005100Timmy the Tiger Pediatric Nebulizer2405432020-08-22
00372217000013Pro-Care Nebulizer EasyEasy2018-12-01
00372217005018ProCare Nebulizer Basic2403912018-11-22
00372217005025Procare Compact Compressor Nebulizer2403922018-12-21
00372217004035Procare Basic Upper Arm BP Monitor2404842020-08-22
00372217004042Procare Upper Arm BP Monitor with XL Cuff2405312020-08-22
00372217039037Procare Spacer Chamber2405302020-08-22
00372217006015"Ultra-Care Pen Needles 31G 1/4"" 100 Ct"2403932018-11-29
00372217006022"Ultra-Care Pen Needles 31G 3/16"" 100 Ct"2403942018-11-29
00372217006039"Ultra-Care Pen Needles 31G 5/16"" 100 Ct"2403952018-11-29
00372217006046"Ultra-Care Pen Needles 32G 1/4"" 100 Ct"2403962018-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810011730748HuahongTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810011730762LinkSunTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810178887750Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00810178887767Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00816042013638FORAFORA CARE INC.FMK2026-06-23
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
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20