IMed Products

GUDID 10810110920214

8" Bonded Extension Set, w / Needle-Free Neutral Valve

ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI

Neutral-pressure intravenous line needleless valve-connector

• Primary Device ID: 10810110920214
• NIH Device Record Key: 7ccee3b6-7b6a-42bf-ab00-d06f23adea91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMed Products
• Version Model Number: IM41058
• Company DUNS: 365581688
• Company Name: ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
• 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

Customer Support Contacts

• Phone: +1(800)969-6331
• Email: info@assetmedical.com
• Phone: +1(800)969-6331
• Email: info@assetmedical.com
• Phone: +1(800)969-6331
• Email: info@assetmedical.com
• Phone: +1(800)969-6331
• Email: info@assetmedical.com
• Phone: +1(800)969-6331
• Email: info@assetmedical.com
• Phone: +1(800)969-6331
• Email: info@assetmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810110920217 [Primary]
GS1	10810110920214 [Package]; Contains: 00810110920217; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221481

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [IMed Products]

• 10810110920221: 14" Bonded Extension Set, w / Needle-Free Neutral Valve
• 10810110920214: 8" Bonded Extension Set, w / Needle-Free Neutral Valve
• 10810110920207: Neutral Displacement Needle-Free Valve