Tenderfoot Newborn Heel Stick Device TF1000I

GUDID 20711234301187

Tenderfoot Newborn Heel Stick Device 1000/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Blood lancet, single-use

• Primary Device ID: 20711234301187
• NIH Device Record Key: f6901e02-cabe-4d38-8086-49e39c26ec72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenderfoot Newborn Heel Stick Device
• Version Model Number: TF1000I
• Catalog Number: TF1000I
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 1000
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com

Device Dimensions

• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter
• Length: 2.5 Millimeter
• Depth: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711234301183 [Unit of Use]
GS1	20711234301187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883968

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
• JCA: Device, Bleeding Time

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-19
• Device Publish Date: 2016-09-22

On-Brand Devices [Tenderfoot Newborn Heel Stick Device]

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