FDA.report

MEDLINE INDUSTRIES, INC.

Primary DI
40080196575733
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
MDS055002ZG
Catalog number
MDS055002ZG
Device description
DBD-BANDAGE,ELASTIC,SURE-WRAP,2"X5YD,CLI
Published
2021-01-19
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

Related Records

Contact Domains

Product Codes

CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30080196575736PackageGS110In Commercial Distribution
40080196575733PackageGS120In Commercial Distribution
10080196575732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3008019657573630080196575736
4008019657573340080196575733
1008019657573210080196575732

GMDN Terms

TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
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20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

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50192253065280CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15