FDA.reportPublic FDA data

Positioning System

Primary DI
07290016936247
Brand
Positioning System
Company
UC-CARE LTD
Model
FPRMC00036
Catalog number
FPRMC00036
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082919000UC-CARE POSITIONING SYSTEMUc-Care Medical Systems, Ltd.2008-10-27EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016936247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016936247072900169362477290016936247

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holder, sterileA sterile device designed to be attached to a patient's body to hold an indwelling urinary catheter (e.g., Foley, ureteral), or a tube attached to it, in place. It typically consists of a wrap placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook/loop closure, spring tensioner) without creating excessive pressure on it and permitting visual inspection of the site. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649551124
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016936278SmartBxFPRMC00037FPRMC000372026-03-29
07290016936322Box of 80 SmartBx Disposable CassettesFPRPR00011FPRPR000112026-03-29
07290016936339Box of 10 SmartBx Disposable Needle CribsFPRPR00012FPRPR000122026-03-29
07290016936360SmartBx Spare partsFPRMC00031FPRMC000312026-03-29
07290016936001Navigo™ Workstation FPRMC0016AFPRMC0016A2017-11-15
07290016936018Computer (Industrial)FPRCO00011FPRCO000112017-11-15
07290016936025Probe sensor assembly for BK 8808 (square)FPRSA00006FPRSA000062017-11-15
07290016936032Probe sensor assembly for BK 8818 and 8808e (square)FPRSA00007FPRSA000072017-11-15
07290016936049Probe sensor assembly for Hitachi V53W (square)FPRSA00008FPRSA000082017-11-15
07290016936056Probe sensor assembly for GE E8CS (square)FPRSA00009FPRSA000092017-11-15
07290016936063Probe sensor assembly for BK 8667 (square)FPRSA00011FPRSA000112017-11-15
07290016936070Probe sensor assembly for MindRayFPRSA00013FPRSA000132017-11-15
07290016936087Probe sensor assembly for GE E8CS FPRSA00014FPRSA000142017-11-15
07290016936094Probe sensor assembly for Hitachi V53W FPRSA00012FPRSA000122017-11-15
07290016936100Ascension transmitter Cubic AssemblyASMCH00034ASMCH000342017-11-15
07290016936117Roll Stand + Arm HRDGN00023HRDGN000232017-11-15
07290016936124Probe sensor assembly for EndoCareFPRSA00015FPRSA000152017-11-15
07290016936131Probe sensor assembly for D&K 8848FPRSA00016FPRSA000162017-11-15
07290016936148Probe sensor assembly for Civco 8848FPRSA00017FPRSA000172017-11-15
07290016936155Probe sensor assembly for Hitachi EUP-U533FPRSA00018FPRSA000182017-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04