Model: 1.0.0
DI: 00850057117516
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
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bae732f7-6b4a-447c-bb04-6c3d1d9834c6
Distribution Status:
In Commercial Distribution
DUNS Number:
117496308
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850057117516
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57967
Name: Medical equipment clinical data interfacing software
Definition:
An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.
FDA Product Codes
MOD
Accessory To Continuous Ventilator (Respirator)
Premarket Submissions
Submission Number:
K260051
Supplement Number:
000