FDA.report

Medline

Primary DI
40080196879237
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDT1006A
Catalog number
DYNDT1006A
Device description
DBD-TRAY,FOLEY INSERTION,COURSEY ENTERPR
Published
2021-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OHRCatheter care tray

Product Code Classifications

CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196879237PackageGS110In Commercial Distribution
10080196879236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019687923740080196879237
1008019687923610080196879236

GMDN Terms

TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge12French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature, Avoid excessive heat. Shield from direct light. Store product away from direct exposure to light at room temperature, preferably in original container.

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
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
true
No natural rubber latex
false
Sterilization required before use
false

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