FDA.report

AtmosAir 9000X

Primary DI
05059441150107
Brand
AtmosAir 9000X
Company
Arjohuntleigh AB
Model
633041
Device description
AtmosAir 9000X Hybrid mattress - 1070 X 2000 X 180 mm (42 X 79 X 7 in) - Top Cover Premium
Published
2022-07-27
Public version status
New
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

Product Codes

CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05059441150107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05059441150107050594411501075059441150107

GMDN Terms

TermDefinition
Foam-filled bed mattress overlayA foam-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, 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. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
355804758
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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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05059441537298AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
05059441537304AIRPALAP-034SPNB AP-034SPNB 2026-03-23
05059441537311AIRPALAP-034SPNBSHAP-034SPNBSH2026-03-23
05059441537328AIRPALAP-039SPNB AP-039SPNB 2026-03-23
05059441537335AIRPALAP-039SPNBSH AP-039SPNBSH2026-03-23
05059441537342AIRPALAP-050SPNB AP-050SPNB 2026-03-23
05059441380450Arjo Loop Ambulatory SlingMLA5100-SMLA5100-S2026-03-09
05059441380467Arjo Loop Ambulatory SlingMLA5100-MMLA5100-M2026-03-09
05059441380474Arjo Loop Ambulatory SlingMLA5100-LMLA5100-L2026-03-09
05059441380481Arjo Loop Ambulatory SlingMLA5100-XLMLA5100-XL2026-03-09
05059441461654TherarestTRMRLNB35579TEGTRMRLNB35579TEG2026-02-10
05056097349510SARA FLEXTSS.500WTSS.500W2022-09-03
05056097364049SARA FLEXTSS.503WTSS.503W2022-09-03
05056097369921SARA FLEXTSS.501WTSS.501W2022-09-03
05056097369938SARA FLEXTSS.502WTSS.502W2022-09-03
05059441536024AtmosAir Velaris633042US633042US2026-01-15
05059441536031AtmosAir Velaris633043US633043US2026-01-15
05059441536048AtmosAir Velaris633044US633044US2026-01-15
05059441536055AtmosAir Velaris633045US633045US2026-01-15
05059441536062AtmosAir Velaris633046US633046US2026-01-15

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