FDA UDI In Commercial Distribution 🇺🇸 United States

VaPro

DI: 00610075092697 · Model: 7600144 · HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30

Basic Information

Brand Name
VaPro
Primary DI
00610075092697
Version / Model
7600144
Catalog Number
7600144
Company Name
HOLLISTER INCORPORATED
Labeler DUNS
005527098
Distribution Status
In Commercial Distribution
Device Count in Pkg
30
Record Status
Published
Publish Date
2026-01-30
Public Version
1
Public Version Date
2026-02-09
Public Version Status
New
Public Device Record Key
58655b01-508f-44cc-8a90-8ca0b9acbf0d

Device Description

No Touch Urethral Intermittent Catheter, Nelaton

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GBM CATHETER, URETHRAL

GMDN Terms

Code Name
45603 Single-administration urethral drainage catheter

Identifiers

Type ID
Unit of Use 20610075092691
Primary 00610075092697

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K233524 000

Device Sizes

Type Value Unit Text
Length 40 Centimeter
Catheter Gauge 14 French

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
14 – 30 Degrees Celsius