Device
Klarity Vacuum Bag 110cm x 57cm, 20 liter fill, with Civco-style valve
Manufacturer
Klarity Medical Products, LLC
Klarity Medical Products, LLC
Model: R7627-20C
DI: 00840510401238
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Klarity Vacuum Bag 110cm x 57cm, 20 liter fill, with Civco-style valve
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
affc1e1d-1705-467c-9550-0e03b37e6c1c
Distribution Status:
In Commercial Distribution
DUNS Number:
034824691
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840510401238
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40895
Name: Vacuum-mould patient positioning system
Definition:
An assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).
FDA Product Codes
IYE
Accelerator, Linear, Medical
Premarket Submissions
Submission Number:
K132124
Supplement Number:
000