Model: 101005
DI: 00615521031015
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Hug-U-Vac® Large Lateral Disposable
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
380cebfc-f13a-46f5-b675-3525e5659d0d
Distribution Status:
In Commercial Distribution
DUNS Number:
004245668
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00615521002084
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
12
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00615521031015
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00615521031015
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 62619
Name: Surgical linen/cushion set
Definition:
A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.
FDA Product Codes
KME
Bedding, Disposable, Medical
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-29
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
60
Storage Handling - Storage Handling Type:
Storage Environment Temperature