FDA.reportPublic FDA data

ALLEN

Primary DI
00615521013127
Brand
ALLEN
Company
ALLEN MEDICAL SYSTEMS, INC.
Model
103006
Catalog number
750287
Device description
FOAM HEAD BLOCK 1 PC.
Published
2023-05-30
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
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
00615521013127PackageGS16In Commercial Distribution
00615521030841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521013127006155210131276155210131270615521013127
00615521030841006155210308416155210308410615521030841

GMDN Terms#

Term, Definition table
TermDefinition
Surgical linen/cushion setA collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use 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
147805894
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521004354ArthrexAR-1627-052024-05-23
00615521004385ArthrexAR-1627-102024-05-23
00615521004392ArthrexAR-1627-112024-05-23
00615521004408ArthrexAR-1627-11EU2024-05-23
00615521004415ArthrexAR-1627-11UK2024-05-23
00615521004422ArthrexAR-1627-122024-05-23
00615521004439ArthrexAR-1627-12EU2024-05-23
00615521004460ArthrexAR-1627-152024-05-23
00615521004491ArthrexAR-1627-172024-05-23
00615521004507ArthrexAR-1627-182024-05-23
00615521004514ArthrexAR-1627-202024-05-23
00615521004521ArthrexAR-1650-012024-05-23
00615521004552ArthrexAR-1650-042024-05-23
00615521004569ArthrexAR-1650-052024-05-23
00615521004583ArthrexAR-1650-072024-05-23
00615521004590ArthrexAR-1650-082024-05-23
00615521004606ArthrexAR-1650-092024-05-23
00615521004613ArthrexAR-1650-102024-05-23
00615521004620ArthrexAR-1650-112024-05-23
00615521004668ArthrexAR-1713-012024-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015560728Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560735Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560759Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560766Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560704Le SquishFiomet Ventures Inc.FMP2026-05-23
00860015560711Le SquishFiomet Ventures Inc.FMP2026-05-23
00860015560742Le SquishFiomet Ventures Inc.FMP2026-05-23
10848530108172CPAP AccessorySUNSET HEALTHCARE SOLUTIONS, INC.FMP2026-02-02
00089904011374Action®ACTION PRODUCTS, INC.FMP2026-01-08
00089904011381Action®ACTION PRODUCTS, INC.FMP2026-01-08
00089904011398Action®ACTION PRODUCTS, INC.FMP2026-01-08
20609271989607Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989614Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989621Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989638Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
00609271989641Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989652Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989669Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989676Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989683Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989690Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989706Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989713Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989720Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989737Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989744Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989751Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989768Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
50749756401437DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01
50749756401444DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01