Tenderfoot Newborn Heel Stick Device TF200I

GUDID 20711234301194

Tenderfoot Newborn Heel Stick Device 200/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 ID20711234301194
NIH Device Record Keyfe6ab376-8396-48e0-acb4-1897c575c67b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTenderfoot Newborn Heel Stick Device
Version Model NumberTF200I
Catalog NumberTF200I
Company DUNS079299318
Company NameACCRIVA DIAGNOSTICS HOLDINGS, INC.
Device Count200
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

Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter
Length2.5 Millimeter
Depth1 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100711234301190 [Unit of Use]
GS120711234301194 [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

On-Brand Devices [Tenderfoot Newborn Heel Stick Device]

20711234301194Tenderfoot Newborn Heel Stick Device 200/box
20711234301187Tenderfoot Newborn Heel Stick Device 1000/box
20711234301163Tenderfoot Newborn Heel Stick Device 50/box

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