ALLEN

Basic Information

• Brand Name: ALLEN
• Primary DI: 00615521002015
• Version / Model: 102002
• Catalog Number: A-60001
• Company Name: ALLEN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 147805894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-26
• Public Version: 1
• Public Version Date: 2023-06-05
• Public Version Status: New
• Public Device Record Key: 32a69a75-5b4b-4562-b13f-c10877f2dd36

Device Description

Hug-U-Vac Steep Trend Positioner

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15325	Patient positioning vacuum pad	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615521002015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]