Primary Device ID | 10653599001377 |
NIH Device Record Key | 5303aecd-7058-4b78-ad2a-c8fed36c1bc3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CathGrip |
Version Model Number | 51250LPNSNA |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00653599001370 [Primary] |
GS1 | 10653599001377 [Package] Contains: 00653599001370 Package: box [30 Units] In Commercial Distribution |
KMK | Device, Intravascular Catheter Securement |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-05 |
Device Publish Date | 2021-02-25 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CATHGRIP 87077049 5128749 Live/Registered |
BioDerm, Inc. 2016-06-20 |