FDA.report

Medline Industries, Inc.

Primary DI
40080196028864
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYND10810
Catalog number
DYND10810
Device description
UNIV/MALE SPECI-CATH KIT 8FR
Published
2022-01-16
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
EZDCatheter, straight
PPBFoley catheter kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196028864PackageGS125In Commercial Distribution
40889942408109PackageGS125In Commercial Distribution
10080196028863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019602886440080196028864
4088994240810940889942408109
1008019602886310080196028863

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing and excessive heat. Shield from direct sunlight.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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

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