FDA.report

Protekt Aire

Primary DI
05060488570070
Brand
Protekt Aire
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
80050
Catalog number
80050
Device description
PROTEKT AIRE 5000 LOW AIR LOSS ALTERNATING PRESSURE MATTRESS SYSTEM
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
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060488570070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060488570070050604885700705060488570070

GMDN Terms

TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Device Sizes

TypeValueUnit
Height6Inch
Length80Inch
Width36Inch

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

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05060488573033Protekt PartsPP-ELRPP-ELR2022-11-18
05060488573040Protekt PartsPP-JRSFPP-JRSF2022-11-18
05060488573057Protekt PartsPP-RAPDPP-RAPD2022-11-18
05060488573064Protekt PartsPP-RATBWPP-RATBW2022-11-18
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