FDA.reportPublic FDA data

VacuumCushion 150x80CPC

Primary DI
08719425705187
Brand
VacuumCushion 150x80CPC
Company
MACROMEDICS B.V.
Model
V15080CPC
Catalog number
155475
Device description
Vacuum Cushion, body support,150x80cm, 65L with CPC valve
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142420000Patient Positioning DevicesMacromedics BV2015-03-27IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719425705187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719425705187087194257051878719425705187

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-mould patient positioning systemAn 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).

Regulatory Flags#

DUNS number
489730120
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720168162595Mask DSPS®-PROSH set/51139102026-04-23
08720168162564DSPS-Prominent® Cradle-II1131502026-04-22
08720168162571Mask DSPS®-PROSHVRL set/51138902026-04-22
08720168162618Mask DSPS®-PROSHL set/51139202026-04-22
08720168162649Mask DSPS®-PROSHVR set/51139402026-04-22
08720168162748Mask DSPS®-PROH, set/51139302026-04-22
08720168162755Mask DSPS®-PRO, set/51139902026-04-22
08720168162779DSPS-Prominent® Cradle-III1131602026-04-22
08720168162786DSPS-Prominent® Cradle-IV1131702026-04-22
08720168162793DSPS-Prominent® Cradle-VI1131802026-04-22
08720168162854Mask DSPS®-PROSCVRL set/51137602026-04-22
08720168162861Mask DSPS®-PROSC set/51137702026-04-22
08720168162878Mask DSPS®-PROSCVR set/51137802026-04-22
08720168162885Mask DSPS®-PROSCL set/51137902026-04-22
08720168163325DSPS-Prominent® Cradle-VII1132602026-04-22
08720168163356DSPS-Prominent® SH profile set/21130902026-04-22
08720168163387DSPS PRO Mask Shim Set HNS1132502026-04-22
08720168163394DSPS PRO Mask Shim Set HO1132702026-04-22
08720168160140DSPS-Prominent® baseplate 1131202026-04-21
08720168162557DSPS-Prominent® Cradle-I1131402026-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
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