Identity
- Trade Name
- aScope BronchoSampler™ SC FDA UDI
- Generic Name
- General-purpose surgical suction system, vacuum FDA UDI
- Device Name
- Ambu aScope BronchSampler container. Single-use and sterile. Volume of container: 30 ml Minimum purchase is 10 pcs. = 1 box FDA UDI
- Model / Reference
- 480300000 FDA UDI
- Description
- Ambu aScope BronchSampler container. Single-use and sterile. Volume of container: 30 ml Minimum purchase is 10 pcs. = 1 box FDA UDI
Identifiers
- Catalog Number
- 480300000 FDA UDI
- Primary DI / UDI-DI
- 05707480137077 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- General-purpose surgical suction system, vacuum FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
aScope BronchoSampler™ SC by Ambu A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ambu A/S
Sources (1)
- FDA UDI a906f939-7019-47bc-8403-686586ac121f 37 fields · synced Jun 1, 2026