Unistik TinyTouch

GUDID 00384701200021

Unistik TinyTouch Preemie .85mm x 1.75mm

OWEN MUMFORD USA INCORPORATED

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use

• Primary Device ID: 00384701200021
• NIH Device Record Key: d3a6335b-6c28-46d9-9f8f-e96e4440f165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik TinyTouch
• Version Model Number: AT 1200
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 50
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384701200007 [Unit of Use]
GS1	00384701200014 [Primary]
GS1	00384701200021 [Package]; Contains: 00384701200014; Package: Sleeve [6 Units]; In Commercial Distribution
GS1	00384701200038 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-30
• Device Publish Date: 2023-03-22

On-Brand Devices [Unistik TinyTouch]

• 00384701267024: Unsitik TinyTouch Low Flow 18G
• 00384701260032: Unistik TinyTouch Full Term individually packaged in a carton, 1.0mm x 2.50mm
• 00384701250026: Unistik TinyTouch Full Term 1.0mm x 2.50mm
• 00384701210037: Unistik TinyTouch Preemie, individually packaged in a carton, .85mm x 1.75mm
• 00384701200021: Unistik TinyTouch Preemie .85mm x 1.75mm