FDA.reportPublic FDA data

Tenderfoot Micro-Preemie Heel Stick Device

Primary DI
20711234312022
Brand
Tenderfoot Micro-Preemie Heel Stick Device
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
TFM50I
Catalog number
TFM50I
Device description
Tenderfoot Micro-Preemie Heel Stick Device 50/box
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
JCADevice, Bleeding Time

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
JCADevice, Bleeding TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911997000TENDERFOOT(R), MODIFICATIONInternational Technidyne Corp.1991-07-17FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20711234312022PrimaryGS10
00711234312028Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2071123431202220711234312022
00711234312028007112343120287112343120280711234312028

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0.65Millimeter
Length1.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-643-1640UDI@accriva.com
1-800-678-0710ilsd_ra.na@werfen.com

Regulatory Flags#

DUNS number
079299318
Device count
50
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10711234170342directCHECK ACT+ Whole Blood Control Level 1000DCGACT-1000DCGACT-12022-01-21
10711234170359directCHECK ACT+ Whole Blood Control, Level 2000DCGACT-2000DCGACT-22022-01-21
10711234170366directCHECK ACT-LR Whole Blood Controls, Level 1000DCGLR-1000DCGLR-12022-01-21
10711234170373directCHECK ACT-LR Whole Blood Control, Level 2000DCGLR-2000DCGLR-22022-01-21
10711234101230Hemochron Whole Blood Coagulation SystemPDAOPDAO2016-09-22
10711234102176Hemochron Whole Blood Coagulation SystemRQCHRTRQCHRT2016-09-22
10711234102183Hemochron Whole Blood Coagulation SystemRQCPRTRQCPRT2016-09-22
10711234102206Hemochron Whole Blood Coagulation SystemQCACTQCACT2016-09-22
10711234107027directCHECK Whole Blood ControlsDCJAPTT-NDCJAPTT-N2016-09-22
10711234107034directCHECK Whole Blood ControlsDCJAPTT-ADCJAPTT-A2016-09-22
10711234107041directCHECK Whole Blood ControlsDCJPT-ADCJPT-A2016-09-22
10711234107058directCHECK Whole Blood ControlsDCJACT-ADCJACT-A2016-09-22
10711234107065directCHECK Whole Blood ControlsDCJCPT-ADCJCPT-A2016-09-22
10711234107072directCHECK Whole Blood ControlsDCJCPT-NDCJCPT-N2016-09-22
10711234107089directCHECK Whole Blood ControlsDCJLR-ADCJLR-A2016-09-22
10711234107096HepCheck Whole Blood ControlDCP214-NDCP214-N2016-09-22
10711234107102HepCheck Whole Blood ControlDCP214-ADCP214-A2016-09-22
10711234170175directCHECK Whole Blood ControlsDCJCAPTT-ADCJCAPTT-A2016-09-22
10711234170229directCHECK Whole Blood ControlsDCJACT-NDCJACT-N2016-09-22
10711234170236directCHECK Whole Blood ControlsDCJPT-NDCJPT-N2016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
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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
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08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
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