FDA.reportPublic FDA data

Medi-Inn

Primary DI
00618125143672
Brand
Medi-Inn
Company
TIDI PRODUCTS, LLC
Model
MI-5419-BULK
Device description
Medi-Inn Urology Drain Bags Frosty Vinyl Fits OEC/GE UroView Tables 20 per Case
Published
2016-10-12
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
false

Product Codes#

Code, Name table
CodeName
MMZTABLE, CYSTOMETRIC, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618125143672PackageGS120Not in Commercial Distribution
01618125143671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125143672006181251436726181251436720618125143672
01618125143671016181251436711618125143671

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10618125192592Grip-Lok3300MWA-NSB3300MWA-NSB2026-06-09
00618125135110Grip-Lok3300MWA-NSB3300MWA-NSB2022-10-18
00618125135455Grip-Lok3300MW-TA-33300MW-TA-32022-10-21
00618125134724Grip-Lok3300M-NSB3300M-NSB2022-10-18
10618125134707Grip-Lok3200S-10PK3200S-10PK2022-10-12
10618125134714Grip-Lok3300M-10PK3300M-10PK2022-10-12
10618125134769Grip-Lok3400L-10PK3400L-10PK2022-10-12
10618125134783Grip-Lok3400LFC-10PK3400LFC-10PK2022-10-13
10618125135148Grip-Lok3309MCS-TA-NSB3309MCS-TA-NSB2024-04-22
10618125192141Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
10618125192172Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
10618125192585Grip-LokMCGLPICC-NSBMCGLPICC-NSB2026-04-15
28481750004016Mermaid MedicalA20100090A201000902022-10-12
00618125134526Grip-Lok3460L3460L2022-10-19
00618125134533Grip-Lok3360MWA3360MWA2022-10-19
00618125134687Grip-Lok3300MEPI3300MEPI2022-10-12
00618125134717Grip-Lok3300M-10PK3300M-10PK2023-06-29
00618125134748Grip-Lok3300MWA3300MWA2022-10-12
00618125134779Grip-Lok3400LFC3400LFC2022-10-13
00618125134809Grip-Lok2200NUZA2200NUZA2022-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841736125271SkytronSKYTRON LLCMMZ2026-05-01
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
07350006950070Sonesta P3Sonesta Medical ABMMZ2025-09-30
07350006950087Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950094Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950117Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950124Sonesta P3Sonesta Medical ABMMZ2025-09-30
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
00817463026429Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026306Oakworks MedicalOAKWORKS, INC.MMZ2023-07-17
00817463026245Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026030Oakworks MedicalOAKWORKS, INC.MMZ2023-06-29
00618125139989TIDITIDI PRODUCTS, LLCMMZ2022-09-29
00618125140008TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157679Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157686Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
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