SF-NIH SF360

GUDID 10887714024518

A single lumen catheter used for injection of radiopaque media and pressure measurements of cardiovascular vessels / chambers.

NUMED, INC.

Angiographic catheter, single-use

• Primary Device ID: 10887714024518
• NIH Device Record Key: d33e2c30-128e-48ff-9848-8977279e4392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SF-NIH
• Version Model Number: 317
• Catalog Number: SF360
• Company DUNS: 114186877
• Company Name: NUMED, 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887714024518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952984

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

Ethylene Oxide

[10887714024518]

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: 2016-09-15

On-Brand Devices [SF-NIH]

• 10887714024525: A simgle lumen catheter used for injection of radiopaque media and pressure measurements of card
• 10887714024518: A single lumen catheter used for injection of radiopaque media and pressure measurements of card