FDA.reportPublic FDA data

CoFlex TLC

Primary DI
10724004621500
Brand
CoFlex TLC
Company
Andover Healthcare, Inc.
Model
"LITE LY2 4"" X 3.8 Yds"
Catalog number
7802TN-24
Device description
"Two-Layer Compression KitLayer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort LITE LY2 4"" X 3.8 Yds"
Published
2022-04-05
Public version status
Update
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
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724004621503PackageGS132In Commercial Distribution
10724004621500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004621503007240046215037240046215030724004621503
1072400462150010724004621500

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and 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
Kit
true
Lot or batch
true
Expiration date on label
true
No 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
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
10724004611877UBZ"NL W/IND TN/WH 4"" "8840UBZ-TN2022-04-05

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00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
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00840117327900"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red"Dynarex CorporationMHW2023-12-20
00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
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00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
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