Device
Tiemann Model Intermittent Urethral Catheter, Coude-Tip, Two Drainage Eyes 12Fr 12/Case
Manufacturer
Bosma Enterprises
Bosma Enterprises
Model: 10-120612
Catalog: 10-120612
DI: 10818634025668
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 12Fr 12/Case
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
33c4daae-24e4-4168-af91-b36b55a31156
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 - Device ID:
00818634025661
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10818634025668
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Shipper Case
Item #3 - Device ID:
20818634025665
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
20
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10818634025668
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:
12
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.