FDA.report

DermaView II

Primary DI
00714196253446
Brand
DermaView II
Company
DERMARITE INDUSTRIES LLC
Model
00253E
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications

CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00714196253446PrimaryGS10
01714196253445Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196253446007141962534467141962534460714196253446
01714196253445017141962534451714196253445

GMDN Terms

TermDefinition
Synthetic polymer semi-permeable film dressing, adhesive, sterileA sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
883925562
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00714196464507AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
00714196052629ComfortGauze Border422622025-01-08
00714196052636ComfortGauze Border422632025-01-08
71419624712486DermaSyn002472024-10-21
01714196500150SilvaKollagen Gel00500005002023-10-04
00714196390028AquaDerm00322E2022-05-02
00714196391780DermaFilm thin with Border00229E2021-09-10
00714196390004Adhesive Tape Remover Pads821002021-09-09
00714196390042AquaDerm00324E2021-09-09
00714196390066AquaRite Extra CMC40220402202021-09-09
00714196390080AquaRite Extra CMC40318403182021-09-09
00714196390103AquaRite Extra CMC404502021-09-09
00714196390127AquaRite Extra CMC406602021-09-09
00714196390141Bordered Foam 4" Round00288E2021-09-09
00714196390165Bordered Foam00297E2021-09-09
00714196390189Bordered Foam00298E2021-09-09
00714196390288Sterile Bordered Gauze112302021-09-09
00714196390301Sterile Bordered Gauze113642021-09-09
00714196390325Sterile Bordered Gauze114102021-09-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05430004283935FlexGRIPBedalKMK2025-12-19
05430000258494FlexGRIPBedalKMK2025-12-03
05430000258654Bedal BedalKMK2025-12-03
05430003674017FlexGRIPBedalKMK2025-12-03
05430003674062FlexGRIPBedalKMK2025-12-03
05430003674239Bedal BedalKMK2025-12-03
05430003674260Bedal BedalKMK2025-12-03
05430004283812Bedal BedalKMK2025-12-03
05430003674116FlexGRIPBedalKMK2025-12-02
05430003674147FlexGRIPBedalKMK2025-12-02
05430003674321FlexGRIPBedalKMK2025-12-02
05430003674468FlexGRIPBedalKMK2025-12-02
05430003674499FlexGRIPBedalKMK2025-12-02
05430003674956FlexGRIPBedalKMK2025-12-02
05430003674987FlexGRIPBedalKMK2025-12-02
05430004283270FlexGRIPBedalKMK2025-12-02
05430004283355FlexGRIPBedalKMK2025-12-02
05430004283386FlexGRIPBedalKMK2025-12-02
05430004283416FlexGRIPBedalKMK2025-12-02
05430004283447FlexGRIPBedalKMK2025-12-02
05430004283478FlexGRIPBedalKMK2025-12-02
05430004283553FlexGRIPBedalKMK2025-12-02
05430004283584FlexGRIPBedalKMK2025-12-02
05430004283737FlexGRIPBedalKMK2025-12-02
05430004283768FlexGRIPBedalKMK2025-12-02
05430004283867FlexGRIPBedalKMK2025-12-02
05430000258173Bedal BedalKMK2025-12-01
05430000258258FlexGRIPBedalKMK2025-12-01
05430003674178FlexGRIPBedalKMK2025-12-01
05430003674208FlexGRIPBedalKMK2025-12-01