FDA.report

INVACARE® MICROAIR® THERAPEUTIC SUPPORT SURFACE

Primary DI
00841447102007
Brand
INVACARE® MICROAIR® THERAPEUTIC SUPPORT SURFACE
Company
INVACARE CORPORATION
Model
MA90ZB48
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
00841447102007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447102007008414471020078414471020070841447102007

GMDN Terms

TermDefinition
Low-air-loss bedA mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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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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
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00841447116400Easy Glide Wheelchair for InvacareEGWC20STREBUEGWC20STREBU2026-02-13
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