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Hobbs Aspiration Catheter

FDA UDI

Class II (US FDA UDI)

by Hobbs Medical, Inc.

Identity

Trade Name
Hobbs Aspiration Catheter FDA UDI
Generic Name
Tracheobronchial suction/insufflation 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
2181 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
2181 FDA UDI
Primary DI / UDI-DI
M84921810 FDA UDI
510(k) Number
K844550 FDA UDI
FDA Product Code
OCX FDA UDI
GMDN Term
Tracheobronchial suction/insufflation 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: Tracheobronchial suction/insufflation 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 Tracheobronchial suction/insufflation catheter, single-lumen.

Cleared under the same submission

K844550 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hobbs Medical, Inc.

Sources (1)

  • FDA UDI 2ea89a71-faeb-4cc6-84d2-d4909d42d4af 36 fields · synced Jun 7, 2026