Tenderfoot Micro-Preemie Heel Stick Device TFM50I

GUDID 20711234312022

Tenderfoot Micro-Preemie Heel Stick Device 50/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use
Primary Device ID20711234312022
NIH Device Record Key5abaac1c-1f48-45d6-8b3d-8ef5b4c30461
Commercial Distribution StatusIn Commercial Distribution
Brand NameTenderfoot Micro-Preemie Heel Stick Device
Version Model NumberTFM50I
Catalog NumberTFM50I
Company DUNS079299318
Company NameACCRIVA DIAGNOSTICS HOLDINGS, INC.
Device Count50
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-643-1640
EmailUDI@accriva.com
Phone1-800-643-1640
EmailUDI@accriva.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com

Device Dimensions

Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter
Length1.4 Millimeter
Depth0.65 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100711234312028 [Unit of Use]
GS120711234312022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
JCADevice, Bleeding Time

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-19
Device Publish Date2016-09-22

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