CovaClear™ IV Cover 4x4

Primary DI
00825439017487
Brand
CovaClear™ IV Cover 4x4
Company
Covalon Technologies Ltd
Model
96C0404
Device description
Clear Silicone Adhesive Securement Dressing
Published
2024-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825439017487PackageGS125In Commercial Distribution
10825439017484PackageGS14In Commercial Distribution
00825439017470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439017487008254390174878254390174870825439017487
1082543901748410825439017484
00825439017470008254390174708254390174700825439017470

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Centimeter
Width4Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
206936101
Device count
1
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00825439012062MediClear™ Scar 10x10900101090010102023-07-14
00825439012260MediClear™ Scar 4x4900040490004042023-07-14
00825439012291MediClear™ Scar 6x7900060790006072023-07-14
00825439012321MediClear™ Scar 6x30900063090006302023-07-14
00825439012789MediClear™ PreOp 70010122018-04-30
00825439012819MediClear PreOp70006302022-12-01
00825439012994MediClear PreOp70006252022-12-01
00825439016169MediClear™ PreOp70008302018-05-18
00825439012871MediClear™ PreOp70006072018-04-30
00825439010136IV Clear 4x4 with crosshairTWBD10112022-11-30
00825439010334SurgiClear 4x4TWBD10222022-12-01
00825439010464IV Clear 4x4TWBD10132022-11-30
00825439011188"ColActive® Plus 2""x2"""55502202022-11-30
00825439011218"ColActive® Plus 4""x4"""55504402022-11-30
00825439011249"ColActive® Plus 7""x7"""55507702022-11-30
00825439011270"ColActive® Plus Ag 2""x2"""55512202022-11-30
00825439011300"ColActive® Plus Ag 4""x4"""55514402022-11-30
00825439011331"ColActive® Plus Ag 7""x7"""55517702022-11-30
00825439013472ColActive® Transfer 4x455504412022-12-05
00825439017241ColActive® Plus Powder80P00012022-11-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850087488358CeeportCEEPORT INC.KMK2026-05-29
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
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20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
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10686004000320UltraDomeI.V. House, Inc.KMK2023-07-21