FDA.report

Protekt O2

Primary DI
05060488570247
Brand
Protekt O2
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
78001
Catalog number
78001
Device description
PROTEKT O2 CUSHION DRY FLOTATION SEATING 16" LOW PROFILE
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KICCushion, Flotation

Product Code Classifications

CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060488570247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060488570247050604885702475060488570247

GMDN Terms

TermDefinition
Air-filled chair cushionA static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device.

Device Sizes

TypeValueUnit
Height2Inch
Length16Inch
Width16Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags

DUNS number
078582655
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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05061105057455Protekt VX 5000PMVSM5000PMVSM50002025-12-18
05060488573989ProtektPMSEBHRPMSEBHR2022-11-23
05060488573996ProtektPMSEBFRPMSEBFR2022-11-23
05060488574009ProtektPMFEBHRPMFEBHR2022-11-23
05060488574016ProtektPMFEBFRPMFEBFR2022-11-23
05060488572920Protekt PartsPP-WLE8GTPP-WLE8GT2022-11-18
05060488572937Protekt PartsPP-WLE8PP-WLE82022-11-18
05060488572944Protekt PartsPP-RATK3PP-RATK32022-11-18
05060488572951Protekt PartsPP-SB48PP-SB482022-11-18
05060488572968Protekt PartsPP-WLE6PP-WLE62022-11-18
05060488572975Protekt PartsPP-RATNWPP-RATNW2022-11-18
05060488572982Protekt PartsPP-RATSWPP-RATSW2022-11-18
05060488573002Protekt PartsPP-HDSFPP-HDSF2022-11-18
05060488573019Protekt PartsPP-RATWWPP-RATWW2022-11-18
05060488573026Protekt PartsPP-SFPP-SF2022-11-18
05060488573033Protekt PartsPP-ELRPP-ELR2022-11-18
05060488573040Protekt PartsPP-JRSFPP-JRSF2022-11-18
05060488573057Protekt PartsPP-RAPDPP-RAPD2022-11-18
05060488573064Protekt PartsPP-RATBWPP-RATBW2022-11-18
05060488573071Protekt PartsPP-RAPFPP-RAPF2022-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00613732114824ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115029ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115074ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115081ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115098ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115104ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115111ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09