Prevahex 1492BOX
GUDID B5591492CASE3
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 3.8 IN x 4.6 IN, 100 Dressings/Case, 1492CH
ENTROTECH LIFE SCIENCES, INC.
Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive Antimicrobial synthetic polymer semi-permeable film dressing, adhesive| Primary Device ID | B5591492CASE3 |
| NIH Device Record Key | 80723547-b295-4317-a471-64efe3cfd96d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prevahex |
| Version Model Number | 1492BOX |
| Catalog Number | 1492BOX |
| Company DUNS | 080030899 |
| Company Name | ENTROTECH LIFE SCIENCES, INC. |
| Device Count | 25 |
| 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 | true |
| 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 | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com | |
| Phone | +1(415)513-4494 |
| info@prevahexchx.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 75 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B5591492BOX1 [Primary] |
| HIBCC | B5591492CASE3 [Package] Contains: B5591492BOX1 Package: CASE [4 Units] In Commercial Distribution |
| HIBCC | B5591492CH0 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140389
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2021-02-26 |
On-Brand Devices [Prevahex]
| B5591488CH00 | Prevahex Antimicrobial Transparent Film Dressing, I.V. Securement |
| B5591488BOX1 | Box of 100 Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement |
| B5591485CH00 | Prevahex Antimicrobial Transparent Film Dressing |
| B5591485BOX1 | Box of 100 Prevahex Antimicrobial Transparent Film Dressings |
| B5591484CH00 | Prevahex Antimicrobial Transparent Film Dressing |
| B5591484BOX1 | Box of 100 Prevahex Antimicrobial Transparent Film Dressings |
| B5591483CH00 | Prevahex Antimicrobial Transparent Film Dressing |
| B5591483BOX1 | Box of 100 Prevahex Antimicrobial Transparent Film Dressings |
| B5591492CASE3 | Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 3.8 IN x 4.6 IN, 100 Dressin |
| B5591491CH0 | Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 2.8 IN x 3.5 IN, 100 Dressin |
Trademark Results [Prevahex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREVAHEX 87978007 5537429 Live/Registered |
Entrotech Life Sciences, Inc. 2017-08-08 |
 PREVAHEX 87560205 not registered Live/Pending |
Entrotech Life Sciences, Inc. 2017-08-08 |
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