FDA.report

POSEY

Primary DI
10190676000262
Brand
POSEY
Company
POSEY PRODUCTS, LLC
Model
5750
Catalog number
5750
Device description
FOAM MATTRESS COVER
Published
2016-09-13
Public version status
Update
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

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20190676000269PackageGS14In Commercial Distribution
10190676000262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019067600026920190676000269
1019067600026210190676000262

GMDN Terms

TermDefinition
Bed mattress/cover setA collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008503294
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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00190676000616POSEY5707H5707H2016-09-13
00190676007653Posey8309WL8309WL2024-10-23
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20190676008036POSEY819981992023-01-25
10190676007636POSEY8645WL8645WL2024-03-11
10190676007643POSEY8282WL8282WL2024-03-11
20190676007909POSEY8645WB8645WB2024-03-11
00190676000975POSEYA8070BA8070B2016-09-19
00190676000999POSEYA8070TFA8070TF2016-09-19
20190676007992POSEY8309SL068309SL062023-06-22
20190676008005POSEY8309SL128309SL122023-06-22
20190676008012POSEY8283SL068283SL062023-06-22
20190676008029POSEY8283SL128283SL122023-06-22
20190676007916POSEY8235NCPP128235NCPP122022-11-02
10618125190666POSEY8334WL8334WL2022-11-02
10190676000217POSEY574257422016-09-13
10190676000224POSEY574357432016-09-13

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