FDA.reportPublic FDA data

AndoFlex TLC

Primary DI
00724004614932
Brand
AndoFlex TLC
Company
Andover Healthcare, Inc.
Model
LT W/IN 4"
Catalog number
ASP-7807TLC-TN
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. AndoFlex® TLC provides a two-step level of comfort. LT W/IN 4"
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
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724004614932PackageGS18In Commercial Distribution
10724004614939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004614932007240046149327240046149320724004614932
1072400461493910724004614939

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11
10192253046304KendallCardinal Health 200, LLCKGX2024-05-29