SafeFill SF100

GUDID 00854989006061

Universal Vial Adapter, 1 each, female luer slip outlet

Q. I. MEDICAL, INC.

Fluid transfer set, general-purpose

• Primary Device ID: 00854989006061
• NIH Device Record Key: 9f89d6dc-d21f-44ca-8557-e76d46bc61dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeFill
• Version Model Number: Universal Vial Adapter
• Catalog Number: SF100
• Company DUNS: 800082950
• Company Name: Q. I. MEDICAL, INC.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854989006061 [Primary]
GS1	00854989006139 [Package]; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921031

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

[00854989006061]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-09

On-Brand Devices [SafeFill]

• 00854989006061: Universal Vial Adapter, 1 each, female luer slip outlet
• 00854989006030: Small Vial Adapter, 1 each, female luer slip outlet, locking flanges
• 00854989006023: Large Vial Adapter, 1 each, female luer slip outlet, locking flanges