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TravelKit contains First Step Kit and Soiled Scope Bag
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- TravelKit contains First Step Kit and Soiled Scope Bag FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- TravelKit contains First Step Kit (200ml EP-4 Kit) and Soiled Scope Bag - 1 Kit FDA UDI
- Model / Reference
- TK200 FDA UDI
- Description
- TravelKit contains First Step Kit (200ml EP-4 Kit) and Soiled Scope Bag - 1 Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356100907 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Endoscopy preparation kit FDA UDI
Classification
- Device Class
- Class I 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
No
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
TravelKit contains First Step Kit and Soiled Scope Bag by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopy preparation kit.
- Endo Carry-On Procedure Kit — MEDIVATORS INC. · Class II
- Custom Procedure Kit — MEDIVATORS INC. · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Endo-Carry-on Procedure Kit — MEDIVATORS INC. · Class II
- Custom Procedure Kit — MEDIVATORS INC. · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Endo Carry-on Procedure Kit — MEDIVATORS INC. · Class II
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Cygnus Medical L.l.c.
Sources (1)
- FDA UDI cfccb3bd-544b-4e85-bbb7-a09cda4c007d 33 fields · synced Jun 1, 2026