Model: ULTR300001
Catalog: ULTR300001
DI: 05415067054920
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
3.0 Software Upgrade Kit
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
05a074e7-2fb4-428b-94ae-5feb9ddf7905
Distribution Status:
In Commercial Distribution
DUNS Number:
018493531
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05415067054920
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
DSK
COMPUTER, BLOOD-PRESSURE
DQK
Computer, diagnostic, programmable
NQQ
SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
Premarket Submissions
Submission Number:
K253459
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Keep dry