FDA.reportPublic FDA data

PVC Hydrophilic Urethral Catheter

Primary DI
06971976786783
Brand
PVC Hydrophilic Urethral Catheter
Company
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Model
H01-18M
Device description
Man normal type,Catheter OD.18Fr
Published
2023-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K212567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212567000PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.2022-12-07EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971976786783PrimaryGS10
86971976786789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971976786783069719767867836971976786783
8697197678678986971976786789

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.

Regulatory Flags#

DUNS number
554453716
Device count
30
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971976786639PVC Hydrophilic Urethral CatheterH01-08M2023-09-26
06971976786660PVC Hydrophilic Urethral CatheterH01-10M2023-09-26
06971976786684PVC Hydrophilic Urethral CatheterH01-12M2023-09-26
06971976786721PVC Hydrophilic Urethral CatheterH01-14M2023-09-26
06971976786752PVC Hydrophilic Urethral CatheterH01-16M2023-09-26
06971976786790PVC Hydrophilic Urethral CatheterH01-08F2023-09-26
06971976786813PVC Hydrophilic Urethral CatheterH01-10F2023-09-26
06971976786851PVC Hydrophilic Urethral CatheterH01-12F2023-09-26
06971976786868PVC Hydrophilic Urethral CatheterH01-14F2023-09-26
06971976786875PVC Hydrophilic Urethral CatheterH01-16F2023-09-26
86971976786635PVC Hydrophilic Urethral CatheterH01-08M2023-09-26
86971976786666PVC Hydrophilic Urethral CatheterH01-10M2023-09-26
86971976786680PVC Hydrophilic Urethral CatheterH01-12M2023-09-26
86971976786727PVC Hydrophilic Urethral CatheterH01-14M2023-09-26
86971976786758PVC Hydrophilic Urethral CatheterH01-16M2023-09-26
86971976786789PVC Hydrophilic Urethral CatheterH01-18M2023-09-26
86971976786796PVC Hydrophilic Urethral CatheterH01-08F2023-09-26
86971976786819PVC Hydrophilic Urethral CatheterH01-10F2023-09-26
86971976786857PVC Hydrophilic Urethral CatheterH01-12F2023-09-26
86971976786864PVC Hydrophilic Urethral CatheterH01-14F2023-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162154MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162161MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162185MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162192MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162208MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162215MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162222MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162239MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162246MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162253MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162260MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162277MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10704411008828AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008835AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008842AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008859AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008873AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02