Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- Insufflation Tubing Set, 10ft, high flow, ULPA 0.1 micron filter funnel connector & swivel luer FDA UDI
- Model / Reference
- 241031 FDA UDI
- Description
- Insufflation Tubing Set, 10ft, high flow, ULPA 0.1 micron filter funnel connector & swivel luer FDA UDI
Identifiers
- Catalog Number
- 241031 FDA UDI
- Primary DI / UDI-DI
- 30326053102814 FDA UDI
- FDA Product Code
- NKC FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
FDA UDI
Category: Endoscopic insufflation tubing set, single-use
Regard™ by Resource Optimization & Innovation, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic insufflation tubing set, single-use.
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- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class II
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- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
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
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI 997c5395-5c80-453d-b465-1c58401fac85 34 fields · synced Jun 8, 2026