Model: Resware BI 30 S/T
DI: 06955623020024
Status: New
MRI: MR Safe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5d3aa44f-09de-41a3-b569-29d86f456fa0
Distribution Status:
In Commercial Distribution
DUNS Number:
548237698
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06955623020024
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66259
Name: Intensive-care patient transport system, ventilatory support, adult
Definition:
A mobile (on wheels) assembly of devices intended to be used to transport an adult patient (e.g., between healthcare facilities) with the in-transit provision of high-level critical care including ventilatory support but not extracorporeal life support. It primarily includes ventilatory equipment (e.g., ventilator, nitric oxide delivery unit) and infusion equipment [e.g., syringe driver(s), infusion pump] with appropriate patient monitors, mounted upon a patient trolley/stretcher; emergency airway clearing/resuscitation equipment may also be included.
FDA Product Codes
BZD
Ventilator, Non-Continuous (Respirator)
Premarket Submissions
Submission Number:
K192177
Supplement Number:
000