FDA.report

Span-America

Primary DI
H9338010AA0
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
EASY AIR
Catalog number
8010AA
Device description
PG EASY AIR STD CONTROL UNIT W/ 3FT CORD
Published
2022-09-13
Public version status
New
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

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H9338010AA0PrimaryHIBCC0

GMDN Terms

TermDefinition
Alternating-pressure pumpAn electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.

Sterilization Methods

Method

Regulatory Flags

DUNS number
073704413
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
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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H933UMX884829Span-AmericaGEOMATTRESSUMX8848-292024-12-03
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