UBZ

Primary DI
00724004619876
Brand
UBZ
Company
Andover Healthcare, Inc.
Model
STD W/IN TN/WH 3"
Catalog number
8830UBZ-SC
Device description
Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. CoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. STD W/IN TN/WH 3"
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
00724004619876PackageGS18In Commercial Distribution
10724004619873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724004619876007240046198767240046198760724004619876
1072400461987310724004619873

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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