Identity
- Trade Name
- Hobbs Medical Mistifier Spray Catheter FDA UDI
- Generic Name
- Endoscopic spray catheter, single-use FDA UDI
- Device Name
- A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device. FDA UDI
- Model / Reference
- 2191 FDA UDI
- Description
- A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 2191 FDA UDI
- Primary DI / UDI-DI
- M84921910 FDA UDI
- 510(k) Number
- K030765 FDA UDI
- FDA Product Code
- EOQ FDA UDIOCX FDA UDI
- GMDN Term
- Endoscopic spray catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI876.1500 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
No
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 spray catheter, single-use
Hobbs Medical Mistifier Spray Catheter by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic spray catheter, single-use.
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Cleared under the same submission
K030765 also covers:
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
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI b70a22eb-9be7-486e-b5c1-26f088fe18a4 36 fields · synced May 30, 2026