Device
Tiemann Model Intermittent Urethral Catheter, Coude-Tip, Two Drainage Eyes 18Fr 12/Case
Manufacturer
Bosma Enterprises
Model: 10-120618 Catalog: 10-120618 DI: 10818634025699 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-14 Current Version: 2026-05-22
Description
Tiemann Model Intermittent Urethral Catheter, Coude-Tip, Two Drainage Eyes 18Fr 12/Case
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: c549610d-1b51-4b26-b99e-27b111100583
Distribution Status: In Commercial Distribution
DUNS Number: 878070325
Device Count: 12
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: Yes
Labeled No NRL: No
Identifiers
Item #1 - Pkg Type: Shipper Case
Item #1 - Device ID: 20818634025696
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 20
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10818634025699
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10818634025699
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Device ID: 00818634025692
Item #3 - Device ID Type: Unit of Use
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 45603
Name: Single-administration urethral drainage catheter
Definition:
A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.
FDA Product Codes
KOD
Catheter, Urological
Device Sizes
Device Size - Size - @attributes - Unit: French
Device Size - Size - @attributes - Value: 18
Device Size - Size Type: Catheter Gauge
Environmental Conditions
Storage Handling - Storage Handling Type: Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text: Keep away from direct sunlight.