FDA.reportPublic FDA data

UBC

Primary DI
00724004613645
Brand
UBC
Company
Andover Healthcare, Inc.
Model
SINGLE RL 3" X 6
Catalog number
UB830C-01
Device description
Unna Boot Calamine A single roll of soft foam impregnated with calamine. SINGLE RL 3" X 6 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
false

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
00724004613645PackageGS112In Commercial Distribution
10724004613642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004613645007240046136457240046136450724004613645
1072400461364210724004613642

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
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08