FDA.report

INVACARE® MICROAIR® ALTERNATING PRESSURE MATTRESS

Primary DI
00841447101802
Brand
INVACARE® MICROAIR® ALTERNATING PRESSURE MATTRESS
Company
INVACARE CORPORATION
Model
MA55
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
00841447101802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447101802008414471018028414471018020841447101802

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(440)329-6000orders@invacare.com
(440) 329-6000orders@invacareamerica.com

Regulatory Flags

DUNS number
076916246
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13
00841447116349Easy Glide Wheelchair for InvacareEGWC18STRSBUEGWC18STRSBU2026-02-13
00841447116356Easy Glide Wheelchair for InvacareEGWC18STRSBKEGWC18STRSBK2026-02-13
00841447116363Easy Glide Wheelchair for InvacareEGWC18STREBKEGWC18STREBK2026-02-13
00841447116370Easy Glide Wheelchair for InvacareEGWC18STREBUEGWC18STREBU2026-02-13
00841447116387Easy Glide Wheelchair for InvacareEGWC20STRSBUEGWC20STRSBU2026-02-13
00841447116394Easy Glide Wheelchair for InvacareEGWC20STRSBKEGWC20STRSBK2026-02-13
00841447116400Easy Glide Wheelchair for InvacareEGWC20STREBUEGWC20STREBU2026-02-13
00841447116417Easy Glide Wheelchair for InvacareEGWC20STREBKEGWC20STREBK2026-02-13
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