Identity
- Trade Name
- Hobbs Aspiration Catheter FDA UDI
- Generic Name
- Irrigation catheter, single-lumen FDA UDI
- Device Name
- A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device. FDA UDI
- Model / Reference
- 2182 FDA UDI
- Description
- A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 2182 FDA UDI
- Primary DI / UDI-DI
- M84921820 FDA UDI
- 510(k) Number
- K844550 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Irrigation catheter, single-lumen FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Irrigation catheter, single-lumen
Hobbs Aspiration Catheter by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation catheter, single-lumen.
- Halyard — Avanos Medical, Inc. · Class II
- MD Resource — Medical Device Resource Corp. · Class I
- Halyard — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- MD Resource — Medical Device Resource Corp. · Class I
- IRR-080-6F — APPLIED MEDICAL RESOURCES CORP. · Class II
Cleared under the same submission
K844550 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI 78009d60-d1ed-46ab-bd19-a529382383f7 36 fields · synced Jun 8, 2026