CathGrip

GUDID 10653599000318

CathGrip Single Strap, Small, Non-Sterile, No Alcohol

BIODERM, INC.

Wearable percutaneous catheter/tube holder

• Primary Device ID: 10653599000318
• NIH Device Record Key: a88d3e81-3a57-4ca9-8a8c-e9f97926f6b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CathGrip
• Version Model Number: 51250NSNA
• Company DUNS: 114773653
• Company Name: BIODERM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653599000311 [Primary]
GS1	10653599000318 [Package]; Contains: 00653599000311; Package: box [30 Units]; In Commercial Distribution
HIBCC	M45651250NSNA0 [Secondary]

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [CathGrip]

• 10653599000592: CathGrip Double Strap, Large, Non-Sterile, No Wipes
• M45654003NS0: CathGrip Oval, Large, Non-Sterile
• M45654002NS0: CathGrip Oval, Small, Non-Sterile
• 10653599000691: CathGrip Oval, Medium, Non-Sterile
• 10653599000530: CathGrip Single Strap, Large, Non-Sterile
• 10653599000431: CathGrip Double Strap, Medium, Non-Sterile
• 00653599001073: CathGrip Double Strap, Large, Non-Sterile
• 10653599000318: CathGrip Single Strap, Small, Non-Sterile, No Alcohol
• 20653599000292: CathGrip Single Strap, Small, Non-Sterile
• 10653599000387: CathGrip Double Strap, Large, Non-Sterile, No Alcohol
• 10653599000912: CathGrip Double Strap, Medium, Non-Sterile, No Wipes
• 10653599000561: CathGrip Single Strap, Large, Sterile Foil Pouch
• 10653599000486: CathGrip Double Strap, Medium, Sterile Foil Pouch
• 10653599000455: CathGrip Double Strap, Medium, Non-Sterile, No Alcohol
• 10653599000400: CathGrip Double Strap, Large, Sterile Foil Pouch, No Alcohol
• 10653599000394: CathGrip Double Strap, Large, Sterile Foil Pouch
• 10653599000325: CathGrip Single Strap, Small, Non-Sterile, No Wipes
• 10653599001155: CathGrip Double Strap, Medium, Low Profile, Sterile Foil Pouch
• 10653599001148: CathGrip Double Strap, Large, Low Profile, Sterile Foil Pouch
• 10653599001131: CathGrip Oval, Medium, Non-Sterile, No Alcohol
• 10653599001124: CathGrip Oval, Small, Non-Sterile, No Alcohol
• 10653599001179: CathGrip Double Strap, Large, No Alcohol, Sterile
• 10653599001162: CathGrip Single Strap, Small, No Alcohol, Sterile
• 10653599000660: CathGrip Single Strap, Large, No Alcohol, Sterile
• 10653599000653: CathGrip Double Strap, Medium, No Alcohol, Sterile
• 10653599000769: CathGrip Oval, Large, Sterile
• 10653599000714: CathGrip Oval, Small, Sterile
• 10653599000684: CathGrip Oval, Medium, Sterile
• 10653599000622: CathGrip PegProtect, Sterile
• 10653599000523: CathGrip Single Strap, Large, Sterile
• 10653599000516: CathGrip Double Strap with Wing Seal, Sterile
• 10653599000417: CathGrip Double Strap, Medium, Sterile
• 10653599000363: CathGrip Double Strap, Large, Sterile
• 10653599000271: CathGrip Single Strap, Small, Sterile
• 10653599000257: CathGrip Single Strap with Wing Seal, Sterile
• 10653599001223: CathGrip Double Strap, Medium, Low Profile, Non-Sterile
• 10653599001216: CathGrip Double Strap, Large, Low Profile, Non-Sterile
• 10653599001278: CathGrip Oval, Small, Sterile Foil Pouch
• 10653599000905: CathGrip Single Strap, Small, Sterile Foil Pouch
• 10653599000493: CathGrip Double Strap, Medium, Sterile Foil Pouch, No Alcohol
• 10653599001353: CathGrip Single Strap, Small, Sterile Foil Pouch, No Wipes
• 10653599001292: Medline Medium LVAD Securement Device, Double Strap, Sterile Foil Pouch
• 10653599001285: Medline Large LVAD Securement Device, Double Strap, Sterile Foil Pouch
• 10653599001384: CathGrip Double Strap with Wing Seal, No Alcohol, Sterile
• 10653599001414: Low Profile CathGrip Double Strap, Large, Sterile
• 10653599001407: Low Profile CathGrip Double Strap, Medium, Sterile
• 10653599001391: Low Profile CathGrip Single Strap, Small, Sterile
• 10653599001377: Low Profile CathGrip Single Strap, Small, Non-Sterile, No Alcohol
• 10653599001360: Low Profile CathGrip Double Strap, Medium, Non-Sterile, No Alcohol
• 10653599001339: Low Profile CathGrip Double Strap, Large, Non-Sterile, No Alcohol