Unistik 3 - Comfort 28G

GUDID 00384701042034

Sterile, single use safety lancet

OWEN MUMFORD LIMITED

Manual blood lancing device, single-use

• Primary Device ID: 00384701042034
• NIH Device Record Key: 632295f5-863a-4b7d-8af4-bcb7410d0b16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik 3 - Comfort 28G
• Version Model Number: AT1042
• Company DUNS: 217266915
• Company Name: OWEN MUMFORD LIMITED
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 770-977-2226
• Email: us.info@owenmumford.com
• Phone: 770-977-2226
• Email: us.info@owenmumford.com

Device Dimensions

• Needle Gauge: 28 Gauge
• Depth: 1.8 Millimeter
• Needle Gauge: 28 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384701042003 [Unit of Use]
GS1	00384701042010 [Primary]
GS1	00384701042034 [Package]; Contains: 00384701042010; Package: Case [40 Units]; In Commercial Distribution

FDA Product Code

• FMK: Lancet, Blood

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: 2019-09-20
• Device Publish Date: 2019-09-12

On-Brand Devices [Unistik 3 - Comfort 28G]

• 00384701044038: Sterile, single use safety lancet
• 00384701042034: Sterile, single use safety lancet