PerfIC Cath™ 7020-1571

GUDID 00851847007055

PerfIC Cath™ Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.

ADAPTA MEDICAL INC

Single-administration urethral drainage catheter

• Primary Device ID: 00851847007055
• NIH Device Record Key: e7afc2ec-64fb-4a11-9983-10a6e86ed2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerfIC Cath™
• Version Model Number: 7020-1571
• Catalog Number: 7020-1571
• Company DUNS: 836441613
• Company Name: ADAPTA 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-329-8355
• Email: brent.janaky@adaptamedical.com

Device Dimensions

• Catheter Gauge: 14 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851847007055 [Primary]
GS1	00851847007062 [Package]; Package: Case of 100 units. [100 Units]; In Commercial Distribution

FDA Product Code

• EZD: Catheter, Straight

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-28

Devices Manufactured by ADAPTA MEDICAL INC

• 00851847007024 - n-Able Cath™: 2018-03-29 n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.
• 00851847007031 - mPower Cath™: 2018-03-29 mPower Cath™ Hydro-Straight Sterile, Single-Use 14 Fr Intermittent Urinary Catheter.
• 00851847007055 - PerfIC Cath™: 2018-03-29PerfIC Cath™ Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.
• 00851847007055 - PerfIC Cath™: 2018-03-29 PerfIC Cath™ Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.