FDA.report

TIDIShield

Primary DI
00618125142170
Brand
TIDIShield
Company
TIDI PRODUCTS, LLC
Model
5418
Device description
TIDIShield Urology Drain Bags Frosty Vinyl Sterile Liebel Flarsheim Uro Drain Frame 20 per Case
Published
2016-10-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MMZTABLE, CYSTOMETRIC, ELECTRIC

Product Code Classifications

CodeDeviceSpecialtyClass
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00618125142170PackageGS120Not in Commercial Distribution
01618125142179PrimaryGS10

GMDN Terms

TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
063519193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
10618125192325POSEY8334WL8334WL2025-12-04
10618125192318AquaGuard50000-SMP50000-SMP2025-09-23
20618125192308Carina570-5439570-54392025-09-22
10618125187123VALO466846682025-08-29
10618125187130VALO466746672025-08-29
10618125187147VALO466646662025-08-29
80618125188716VALO100636610063662025-08-29
80618125188723VALO100636710063672025-08-29
80618125188730VALO100636810063682025-08-29
10618125189950VALO466946692025-08-29
80618125190177VALO100980810098082025-08-29
10618125190185VALO466546652025-08-29
20618125114669Sirona20809B63101202025-07-10
10618125192264Steris31780BF458 (056404-710)2025-07-01
10618125192271Steris31780 N/SBF459 (056404-709)2025-07-01
20618125192254Posey806080602024-12-23
00618125192144Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
00618125192175Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
00618125192182Grip-Lok3400L-10PK3400L-10PK2024-12-02
00618125192199Grip-Lok3300M-10PK3300M-10PK2024-12-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
00817463026429Imaging and Pain ManagementOAKWORKS, INC.MMZ2023-12-06
00817463026436Imaging and Pain ManagementOAKWORKS, INC.MMZ2023-12-06
00817463026306Imaging and Pain ManagementOAKWORKS, INC.MMZ2023-07-17
00817463026245Imaging and Pain ManagementOAKWORKS, INC.MMZ2023-07-10
00817463026269Imaging and Pain ManagementOAKWORKS, INC.MMZ2023-07-10
00817463026030Imaging and Pain ManagementOAKWORKS, INC.MMZ2023-06-29
10618125139986TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140005TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140081TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157447DASSETIDI PRODUCTS, LLCMMZ2022-09-29
10618125157676Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157683Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157966Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157973Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125158093Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125158116Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125158123Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125139993TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125140012TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125140098TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125140135TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125140982TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125141118TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125141125TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125142986TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-28
10618125155450SteriGearTIDI PRODUCTS, LLCMMZ2022-09-27