GVS

GUDID 20810197810177

Blood Transfusion Filter

Gvs Tm, Inc.

Blood transfusion filter

• Primary Device ID: 20810197810177
• NIH Device Record Key: a875c8fb-0714-4513-be01-5c808cf58d30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GVS
• Version Model Number: SQ40s
• Company DUNS: 119067149
• Company Name: Gvs Tm, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810197810170 [Primary]
GS1	20810197810177 [Package]; Contains: 10810197810170; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960993

FDA Product Code

• CAK: Microfilter, Blood Transfusion

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: 2026-01-27
• Device Publish Date: 2026-01-19