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AMSure® Urethral Catheterization Tray 15Fr
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS87114KRef AS87116Ref AS87114Ref AS870Ref AS870K
Identity
- Trade Name
- AMSure® Urethral Catheterization Tray EUDAMEDFDA UDIAMSure® Urethral Catheterization Tray 15Fr FDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Device Name
- Urinary Catheterization/ Collection Kit EUDAMEDAMSure® Urethral Catheterization Tray 15Fr Contents: 1 each Red Rubber Urethral Catheter; 1 each 1000mL Outer Basin Tray; 1 pair Vinyl Gloves; 1 each Waterproof Drape; 1 each Fenestrated Drape; 1 pack Lubricating Jelly; 1 each 4 oz Specimen Cup; 1 pack PVP swabstick(3) FDA UDIAMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup FDA UDIAMSure® Urethral Catheterization Tray 14Fr CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Red Rubber Urethral Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDIAMSure® Urethral Catheterization Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 14 Fr. Vinyl Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDIAMSure® Urethral Catheterization Tray CONTENTS: 1 each 14Fr Vinyl Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup FDA UDI
- Model / Reference
- AS87114K EUDAMEDAS87116 EUDAMEDAS87114 EUDAMEDAS870 EUDAMEDAS870K EUDAMED1 FDA UDI
- Description
- AMSure® Urethral Catheterization Tray 15Fr Contents: 1 each Red Rubber Urethral Catheter; 1 each 1000mL Outer Basin Tray; 1 pair Vinyl Gloves; 1 each Waterproof Drape; 1 each Fenestrated Drape; 1 pack Lubricating Jelly; 1 each 4 oz Specimen Cup; 1 pack PVP swabstick(3) FDA UDIAMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup FDA UDIAMSure® Urethral Catheterization Tray 14Fr CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Red Rubber Urethral Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDIAMSure® Urethral Catheterization Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 14 Fr. Vinyl Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDIAMSure® Urethral Catheterization Tray CONTENTS: 1 each 14Fr Vinyl Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup FDA UDI
Identifiers
- Catalog Number
- AS87115 FDA UDIAS87114 FDA UDIAS87114K FDA UDIAS870K FDA UDIAS870 FDA UDIAS87116 FDA UDI
- Primary DI / UDI-DI
- 10704411003786 EUDAMEDFDA UDI10704411007524 EUDAMEDFDA UDI10704411007609 EUDAMEDFDA UDI10704411003779 EUDAMEDFDA UDI10704411003793 EUDAMEDFDA UDI10704411007630 FDA UDI
- Basic UDI-DI
- B-10704411007524 EUDAMEDB-10704411003793 EUDAMEDB-10704411003786 EUDAMEDB-10704411003779 EUDAMEDB-10704411007609 EUDAMED
- FDA Product Code
- FCM FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Intermittent urethral catheterization kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDIFDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent urethral catheterization kit
AMSure® Urethral Catheterization Tray 15Fr by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral catheterization kit.
- TruCath — H R Pharmaceuticals, Inc. · Class II
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- GLOBAL HEALTHCARE — GHC HEALTHCARE, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- TruCath — H R Pharmaceuticals, Inc. · Class II
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
- TruCath — H R Pharmaceuticals, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (11)
- FDA UDI 4d04468c-d14e-414c-9587-f3114316bd3c 34 fields · synced Aug 1, 2026
- FDA UDI 5a94a61b-f49e-4120-a872-0bc5cb29aeed 34 fields · synced May 30, 2026
- FDA UDI cc904c4d-ccb6-4212-94bf-1fe4bafb29ac 34 fields · synced May 30, 2026
- FDA UDI 867ee483-76af-4cf4-9928-a6c31203dc49 34 fields · synced May 30, 2026
- FDA UDI f7bae4d8-d7ac-40a1-8ffa-bf53535b537c 34 fields · synced May 30, 2026
- FDA UDI 1c19a43e-c12b-4262-89a9-a367b766e983 34 fields · synced May 30, 2026
- EUDAMED 29b19a0e-3ba7-40cf-9317-799c602ca3f2 61 fields · synced Jul 9, 2026
- EUDAMED d5dceadf-053e-42c1-bdc1-f864e4cece89 61 fields · synced Jul 10, 2026
- EUDAMED 6df0e951-1879-4063-9309-a6180f37f41e 61 fields · synced Jul 16, 2026
- EUDAMED 8b0649ac-d71b-46c6-80a8-918af7067773 61 fields · synced Jul 30, 2026
- EUDAMED d0aac66a-342c-45b9-b1d6-545d47a5ac9b 61 fields · synced Aug 1, 2026