FDA.reportPublic FDA data

Span-America

Primary DI
H933A80365329
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
Atlas
Catalog number
A80365329
Device description
903350-0 Atlas 36/53x80 w/FS
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KIYChamber, Slide Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIYChamber, Slide CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H933A80365329PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073704413
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H93338036Span-AmericaAPM-i380362026-04-13
H93338042Span-AmericaAPM-i380422026-04-13
H93338436Span-AmericaAPM-i384362026-04-13
H93338442Span-AmericaAPM-i384422026-04-13
H9336200Span-AmericaAPM-i62002026-04-13
H933EZ161896Span-AmericaEZ-DISHEZ1618-962026-02-26
H93392270Span-AmericaSpan Care Convertible922702026-02-25
H933P11634Span-AmericaFloor LiftP116342025-12-03
H933PR13051Span-AmericaOSKA APM2PR13-0512025-12-01
H93353893Span-AmericaGEOMATTRESS 350538932025-12-01
H93332864Span-AmericaCUSTOM CARE LAL328642025-09-09
H93355696Span-AmericaCUSTOM CARE LAL2025-09-09
H93384683Span-AmericaCUSTOM CARE LAL846832025-09-09
H93392474Span-AmericaCUSTOM CARE LAL924742025-09-09
H93331629Span-AmericaPlus316292025-09-04
H93313584Span-AmericaPlus135842025-09-04
H93335834Span-AmericaGEOMATTRESS358342025-08-04
H93338296Span-AmericaGEOMATTRESS382962025-08-04
H93350746CN16Span-AmericaGeomattress50746-CN162022-12-06
H93350077116Span-AmericaSpan Aids50077-1162022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974669350315MDHCMDHC Life Technologies (Kunshan) Co., LTD.KIY2023-07-06