FDA.report

Synthetic Sheepskin Bed Overlay

Primary DI
00810006683370
Brand
Synthetic Sheepskin Bed Overlay
Company
PRIMO INC
Model
SS3040
Catalog number
SS3040
Device description
Synthetic Sheepskin Bed Overlay (30" x 40")
Published
2019-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810006683370PackageGS16In Commercial Distribution
00810006682373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006683370008100066833708100066833700810006683370
00810006682373008100066823738100066823730810006682373

GMDN Terms

TermDefinition
Patient transfer turning sheetA 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/rolling techniques to move the person. It is typically designed to turn the person from one side to another whilst he/she is lying in bed; a practice done in order to prevent bedsores and improve blood circulation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
958758146
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
false
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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