FDA.reportPublic FDA data

Coflex

Primary DI
10724004331157
Brand
Coflex
Company
Andover Healthcare, Inc.
Model
"CPK, 3"" x 5 Yds"
Catalog number
3300CP-024
Device description
"CoFlex Self Adhering Compression Bandage, CPK, 3"" x 5 Yds"
Published
2022-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724004331150PackageGS124In Commercial Distribution
10724004331157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004331150007240043311507240043311500724004331150
1072400433115710724004331157

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, Hevea-latex, single-useA strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
088528245
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724004610757CoFlex TLC"LT TN/LB W/IN 4"""7802TLC-TN2022-04-05
10724004611303Coflex TLC"XL REG TN/LB 4"""7800TLC-XL2022-04-05
10724004620848CoFlex TLC"LS STD TAN/LB 4"""7900TLC-TN2022-04-05
10724004620855CoFlex TLC"LS LT TAN/LB 4"" "7902TLC-TN2022-04-05
10724004621463CoFlex TLC"LY1 FOAM 2"" X 1.3 Yds"7800TN-122022-04-05
10724004621470CoFlex TLC"LY1 FOAM 4"" X 3.8 Yds"7800TN-142022-04-05
10724004621487CoFlex TLC"LY1 FOAM 6"" X 3.8 Yds"7800TN-162022-04-05
10724004621494CoFlex TLC" LITE LY2 1"" X 3.8 Yds"7802TN-212022-04-05
10724004621500CoFlex TLC"LITE LY2 4"" X 3.8 Yds"7802TN-242022-04-05
10724004621517CoFlex TLC"STD LYR2 2"" X 3 Yds"7800TN-222022-04-05
10724004621524CoFlex TLC"STD LYR2 4"" X 5 Yds"7800TN-242022-04-05
10724004621531CoFlex TLC"STD LYR2 6"" X 5 Yds"7800TN-262022-04-05
10724004621661CoFlex TLC"LY1 FOAM 3"" X 3 Yds"7800TN-132022-04-05
10724004621678CoFlex TLC"LITE LY2 3"" X 3.8Yds"7802TN-222022-04-05
10724004621685CoFlex TLC"LTE LY2 6"" X 3.8 Yds"7802TN-262022-04-05
10724004621692CoFlex TLC"LY1 FOAM 6"" X 3 Yds"7802TN-162022-04-05
10724004610672Coflex TLC"Tan, 4"""7800TLC-TN2022-03-22
10724004611815UBC"NL W/IND TN/PK 3"""8830UBC-TN2022-04-05
10724004611839UBC"W/IND TN/PK 4"""8840UBC-TN2022-04-05
10724004611853UBZ"NL W/IND TN/WH 3"""8830UBZ-TN2022-04-05

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07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
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