CathGrip
GUDID 10653599001421
CathGrip Oval, Large, Non-Sterile, No Alcohol
BIODERM, INC.
Wearable percutaneous catheter/tube holder| Primary Device ID | 10653599001421 |
| NIH Device Record Key | 21ef2d85-412f-4cba-937c-fae7b4074b25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CathGrip |
| Version Model Number | 54003NSNA |
| 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
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 |
| 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 | 00653599001424 [Primary] |
| GS1 | 10653599001421 [Package] Contains: 00653599001424 Package: box [30 Units] In Commercial Distribution |
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 | 2021-05-31 |
| Device Publish Date | 2021-05-21 |
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 |
Trademark Results [CathGrip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CATHGRIP 87077049 5128749 Live/Registered |
BioDerm, Inc. 2016-06-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.