Model: HP3500
DI: 00763000446246
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
HEART POSITIONER HP3500 URCHIN EVO GBL
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0aed3eb4-360f-4c9b-94bc-6ef13849b1b2
Distribution Status:
In Commercial Distribution
DUNS Number:
006261481
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:
00763000446246
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 15325
Name: Patient positioning vacuum pad
Definition:
A device designed to position and immobilize parts of the patient (e.g., head, extremities) typically during therapeutic interventions or patient transportation. The device immobilizes a body part by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the part that it encompasses until the vacuum is released.
FDA Product Codes
MWS
Stabilizer, heart