FDA.reportPublic FDA data

Coflex

Primary DI
00724004311152
Brand
Coflex
Company
Andover Healthcare, Inc.
Model
CPK, 1" x 5 yds.
Catalog number
3100CP-030
Device description
CoFlex self adhering compression bandage, CPK, 1" 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
Rx
false
OTC
true
Sterile
false
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
00724004311152PackageGS130In Commercial Distribution
10724004311159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004311152007240043111527240043111520724004311152
1072400431115910724004311159

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088528245
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
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
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580676New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580911New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196691159MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745593MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745647MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745722MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
10080196789207MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-02
10080196823536MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-30
10080196692378MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10080196823543MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10097604110577Tronex International, Inc.TRONEX INTERNATIONAL, INC.FQM2025-05-05