Phenom™ Catheter FG13150-1015-2J

GUDID 00814584023757

Phenom™ 21 Catheter

CATHERA, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00814584023757
• NIH Device Record Key: 68007dc2-ce54-4456-9bf3-f76962e805bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phenom™ Catheter
• Version Model Number: FG13150-1015-2JV01
• Catalog Number: FG13150-1015-2J
• Company DUNS: 080116681
• Company Name: CATHERA, 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

Customer Support Contacts

• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com
• Phone: +1-949-837-3700
• Email: cerreport@covidien.com

Device Dimensions

• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 150 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814584023757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151638

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-10-20

On-Brand Devices [Phenom™ Catheter]

• 00814584029247: Phenom™ Plus Catheter
• 00814584029230: Phenom™ Plus Catheter
• 00814584029223: Phenom™ Plus Catheter
• 00814584029216: Phenom™ Plus Catheter
• 00814584029209: Phenom™ Plus Catheter
• 00814584029193: Phenom™ Plus Catheter
• 00814584029186: Phenom™ Plus Catheter
• 00814584029179: Phenom™ Plus Catheter
• 00814584029162: Phenom™ Plus Catheter
• 00814584029155: Phenom™ Plus Catheter
• 00814584029148: Phenom™ Plus Catheter
• 00814584029131: Phenom™ Plus Catheter
• 00814584029117: Phenom™ Plus Catheter
• 00814584029100: Phenom™ Plus Catheter
• 00814584029094: Phenom™ Plus Catheter
• 00814584029025: Phenom™ 27 Catheter
• 00814584029018: Phenom™ 27 Catheter
• 00814584029001: Phenom™ 27 Catheter
• 00814584028998: Phenom™ 27 Catheter
• 00814584028981: Phenom™ 27 Catheter
• 00814584028974: Phenom™ 27 Catheter
• 00814584028967: Phenom™ 27 Catheter
• 00814584028950: Phenom™ 27 Catheter
• 00814584028943: Phenom™ 27 Catheter
• 00814584028806: Phenom™ 21 Catheter
• 00814584028790: Phenom™ 21 Catheter
• 00814584028752: Phenom™ 21 Catheter
• 00814584028745: Phenom™ 21 Catheter
• 00814584028325: Phenom™ 21 Catheter
• 00814584028318: Phenom™ 21 Catheter
• 00814584028271: Phenom™ 21 Catheter
• 00814584028264: Phenom™ 21 Catheter
• 00814584027847: Phenom™ 21 Catheter
• 00814584027830: Phenom™ 21 Catheter
• 00814584027793: Phenom™ 21 Catheter
• 00814584027786: Phenom™ 21 Catheter
• 00814584027380: Phenom™ 21 Catheter
• 00814584027373: Phenom™ 21 Catheter
• 00814584027366: Phenom™ 21 Catheter
• 00814584027359: Phenom™ 21 Catheter
• 00814584027335: Phenom™ 21 Catheter
• 00814584027328: Phenom™ 21 Catheter
• 00814584027311: Phenom™ 21 Catheter
• 00814584027304: Phenom™ 21 Catheter
• 00814584026888: Phenom™ 17 Catheter
• 00814584026871: Phenom™ 17 Catheter
• 00814584026833: Phenom™ 17 Catheter
• 00814584026826: Phenom™ 17 Catheter
• 00814584026406: Phenom™ 17 Catheter
• 00814584026390: Phenom™ 17 Catheter