Model: X1
Catalog: X1-BT-70M
DI: G035X1BT70M0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
X1 TROLLEY
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
68a4df98-4b6b-4964-8c36-3853fcb74ed1
Distribution Status:
In Commercial Distribution
DUNS Number:
435827526
Device Count:
1
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G035X1BT70M0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 40596
Name: Electromechanical device/system transport trolley
Definition:
A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.
FDA Product Codes
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
5
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
85
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-20
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
60
Item #2 - Storage Handling Type:
Storage Environment Temperature