FDA UDI In Commercial Distribution 🇺🇸 United States

CleanCapture Aspiration Catheter

DI: M84921890 · Model: 2189 · HOBBS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
CleanCapture Aspiration Catheter
Primary DI
M84921890
Version / Model
2189
Catalog Number
2189
Company Name
HOBBS MEDICAL, INC.
Labeler DUNS
076769355
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-14
Public Version
1
Public Version Date
2026-01-22
Public Version Status
New
Public Device Record Key
3a1a7991-6c29-4bcf-8fed-1a598cd68601

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
OCX Endoscopic Irrigation/Suction System

GMDN Terms

Code Name
34923 Suction system catheter, general-purpose

Identifiers

Type ID
Package M84921891
Primary M84921890

Customer Contacts

Phone
8606845875

Premarket Submissions

Submission Number Supplement Number
K241874 000

Device Sizes

Type Value Unit Text
Outer Diameter 2.77 Millimeter
Catheter Working Length 160 Centimeter