Identity
- Trade Name
- Endo Carry-on Procedure Kit FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, 5-piece Olympus DCA Kit, Drawstring Pad, Lubricant, Gauze, Duoswift Squeegee Cleaning and Valve Brush, Suction Tubing, Gown, LL Syringe, Tip Protector, Bite Block, Nasal Canula. Solidifier and Dirty Scope Label. FDA UDI
- Model / Reference
- 4010288 FDA UDI
- Description
- Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, 5-piece Olympus DCA Kit, Drawstring Pad, Lubricant, Gauze, Duoswift Squeegee Cleaning and Valve Brush, Suction Tubing, Gown, LL Syringe, Tip Protector, Bite Block, Nasal Canula. Solidifier and Dirty Scope Label. FDA UDI
Identifiers
- Catalog Number
- 4010288 FDA UDI
- Primary DI / UDI-DI
- 00677964150012 FDA UDI
- FDA Product Code
- NWU FDA UDI
- GMDN Term
- Endoscopy preparation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopy preparation kit
Endo Carry-on Procedure Kit by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopy preparation kit.
- Compliance EndoKit™ — Boston Scientific · Class I
- Compliance EndoKit™ — Boston Scientific · Class I
- VIA — US Endoscopy · Class II
- VIA — US Endoscopy · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Compliance EndoKit™ — Boston Scientific · Class I
- Compliance EndoKit™ — Boston Scientific · Class I
- VIA — US Endoscopy · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medivators Inc.
Sources (1)
- FDA UDI 34d01b92-a558-4c19-b523-fbc4fa841041 35 fields · synced May 30, 2026