FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344162243
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
UR4PVC1616LC
Catalog number
UR4PVC1616LC
Device description
COUDE TIP 16FR 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZDCatheter, straight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220722000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344162243PackageGS130In Commercial Distribution
10197344162246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734416224320197344162243
1019734416224610197344162246

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50850058254451EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
00850058254463EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254475EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254482EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254499EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254505EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254512EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254529EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254536EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254543EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254550EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254567EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
05708932778275SpeediCath Flex SetColoplast A/SEZD2026-02-05
05708932778282SpeediCath Flex SetColoplast A/SEZD2026-02-05
07333387054537LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054575LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054605LoFric® Origo™Wellspect ABEZD2025-11-24
20197344162021MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162045MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162052MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162069MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162076MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162113MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162120MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162137MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162144MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162151MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162168MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162182MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162199MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22