n-Able Cath™ 7025-2020

GUDID 00851847007024

n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.

ADAPTA MEDICAL INC

Single-administration urethral drainage catheter

• Primary Device ID: 00851847007024
• NIH Device Record Key: ae16aef5-f62f-4014-87f7-95de2f8fb243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n-Able Cath™
• Version Model Number: 7025-2020
• Catalog Number: 7025-2020
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851847007000 [Primary]
GS1	00851847007017 [Package]; Contains: 00851847007000; Package: Inner box of 30 [30 Units]; In Commercial Distribution
GS1	00851847007024 [Package]; Contains: 00851847007017; Package: Case of 12 inner box [12 Units]; In Commercial Distribution

FDA Product Code

• GBM: Catheter, Urethral

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