FDA.reportPublic FDA data

ALLEN

Primary DI
00615521017712
Brand
ALLEN
Company
HILL-ROM, INC.
Model
900113
Catalog number
H-403-05-960
Device description
"Astrus Elite 4"", Skytron Ctrd a/b pad"
Published
2023-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, skin pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615521017712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521017712006155210177126155210177120615521017712

GMDN Terms#

Term, Definition table
TermDefinition
Operating table mattress, basicA foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
004245668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521002848ALLEN1030062026-04-24
00615521031008ALLEN1010052026-04-24
00615521031015ALLEN1010052026-04-24
00615521031022ALLEN1020082026-04-24
00615521070007ALLEN1030062026-04-24
00848340016806ALLENA-212002026-04-24
00887761981720Heart and Respiration Rate Monitoring System powered by EarlySenseP2115602021-09-23
00887761985155Heart and Respiration Rate Monitoring System powered by EarlySenseP2008982018-08-22
00887761976870pro+P7924ARENT022026-04-21
00887761007536pro+P3255A072026-04-20
00887761007543pro+P3255A082026-04-20
00887761976863pro+P7924ARENT012026-04-20
00887761976887pro+P3255ARENT012026-04-20
00887761943148WAVE Clinical PlatformDB2026-03-31
00887761007666pro+P7924A142026-03-27
00887761007697pro+P7924ARENT032026-03-27
00887761007703pro+P7924ARENT042026-03-27
00887761007505pro+P006800A062026-03-25
00887761007512pro+P006800A072026-03-25
00887761007550pro+P3255A092026-03-25

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20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
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00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
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00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166141DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166158DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166165DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166172DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166189DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08