Device
Klarity Vacuum Bag 70cm x 50cm, 10 liter fill, with Civco-style valve
Manufacturer
Klarity Medical Products, LLC
Model: R7301-10C DI: 00840510401207 Status: New MRI: MR Conditional Single-use: No Rx: No OTC: No
First Published: 2026-05-05 Current Version: 2026-05-13
Description
Klarity Vacuum Bag 70cm x 50cm, 10 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: fcea5e12-192d-453e-916c-3bfae32424e6
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: 00840510401207
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