FDA.report

ALLEN

Primary DI
00615521013370
Brand
ALLEN
Company
ALLEN MEDICAL SYSTEMS, INC.
Model
900110
Catalog number
F-83016
Device description
Wide Board Replacement Cap
Published
2023-05-31
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

Contact Domains

Product Codes

CodeName
FMRDEVICE, TRANSFER, PATIENT, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615521013370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521013370006155210133706155210133700615521013370

GMDN Terms

TermDefinition
Patient transfer sliding boardA manual device used by healthcare professionals to assist in the physical movement and transfer of a person/patient (e.g., a hospitalized, a person with a disability, or a geriatric) from one position to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the person. It is typically designed to transfer a person sideways from, e.g., a bed to a chair, or a bed to an operating table, or an operating table to a bed. It may be constructed as a solid sliding board with a low-friction surface, or a roller board (roller system in a framework).

Sterilization Methods

Method

Contacts

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

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