Identity
- Trade Name
- Single-Use flexible Video Bronchoscope FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Model / Reference
- BCV1-0M1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197480726 FDA UDI
- 510(k) Number
- K191828 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible video bronchoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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
No
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
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: Flexible video bronchoscope, single-use
Single-Use flexible Video Bronchoscope by Hunan Vathin Medical Instrument Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video bronchoscope, single-use.
- aScope™ 5 Broncho HD 5.0/2.2 Sampler Set — Ambu A/S · Class II
- aScope™ 4 Broncho Slim 3.8/1.2 — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · Class II
- aScope™ 4 Broncho Large 5.8/2.8 — Ambu A/S · Class II
- aScope™ 5 Broncho 4.2/2.2 Sampler Set — Ambu A/S · Class II
- GlideScope® — Verathon Medical (Canada) ULC · Class II
- aScope™ 5 Broncho HD 5.6/2.8 Sampler Set — Ambu A/S · Class II
- LoopView® — MacroLux Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K191828 also covers:
- Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
- Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
- Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
- Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd
Sources (1)
- FDA UDI fda255da-ca55-4c2b-a132-50775dc65218 33 fields · synced Jun 8, 2026