FDA.report

MEDLINE

Primary DI
20197344162113
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
UR4PVC1016L
Catalog number
UR4PVC1016L
Device description
STRAIGHT TIP 10FR 16" HYDROPHILIC COATED
Published
2025-09-22
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

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K220722000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K220722000PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.2023-05-22EZD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344162113PackageGS130In Commercial Distribution
10197344162116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734416211320197344162113
1019734416211610197344162116

GMDN Terms

TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, single-useA flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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