FDA.report

Joerns DermaFloat LR Mattress

Primary DI
00857268006325
Brand
Joerns DermaFloat LR Mattress
Company
JOERNS HEALTHCARE, LLC
Model
DermaFloat LR
Catalog number
DFLR-3680-M
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00857268006325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00857268006325008572680063258572680063250857268006325

GMDN Terms

TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Sterilization Methods

Method

Contacts

PhoneEmail
800-826-0270xxx@xxx.xxx

Regulatory Flags

DUNS number
790937150
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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