FDA.reportPublic FDA data

CoFlex TLC

Primary DI
00724004621497
Brand
CoFlex TLC
Company
Andover Healthcare, Inc.
Model
LITE LY2 1" X 3.8 Yds
Catalog number
7802TN-21
Device description
Two-Layer Compression Kit Layer 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 1" X 3.8 Yds
Published
2022-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00724004621497PackageGS136In Commercial Distribution
10724004621494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004621497007240046214977240046214970724004621497
1072400462149410724004621494

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of non-sterile 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 (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 or healthcare facility. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088528245
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724004605251Coflex LF2TAN, 4" X 5 Yds9400TN-0182022-04-05
00724004311152CoflexCPK, 1" x 5 yds.3100CP-0302022-04-05
00724004321076CoflexTAN 2"X5Yds3200TN-0362022-04-05
00724004321151CoflexCPK, 2" x 5 Yds3200CP-0362022-04-05
00724004331020CoflexBLUE, 3"X 5 Yds3300BL-0242022-04-05
00724004331075CoflexTan 3"X5 Yds3300TN-0242022-04-05
00724004331150CoflexCPK, 3" x 5 Yds3300CP-0242022-04-05
10724004341071CoflexTAN, 4" X 5 Yds3400TN-0182022-04-05
00724004341159CoflexCPK, 4"X5 Yds3400CP-0182022-04-05
00724004402522Coflex NLCPK, 2"X5Yds5200CP-0362022-04-05
00724004511071CoFlex NLTAN, 1"X5Yds5100TN-0302022-04-05
00724004511156Coflex NLCPK, 1"X5Yds5100CP-0302022-04-05
00724004521070Coflex NLTAN 2" X 5Yds5200TN-0362022-04-05
00724004531024Coflex NLBLUE 3" X 5 Yds5300BL-0242022-04-05
00724004531079Coflex NLTAN, 3" X 5 Yds5300TN-0242022-04-05
00724004531154Coflex NLCPK, 3" X 5 Yds5300CP-0242022-04-05
00724004541023Coflex NLBLUE, 4" X 5 Yds5400BL-0182022-04-05
00724004541078Coflex NLTAN, 4" X 5 Yds5400TN-0182022-04-05
00724004541153Coflex NLCPK, 4" X 5 Yds5400CP-0182022-04-05
00724004601918Coflex NL KIDSPACK 3"X5YD5300KP-0242022-04-05

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