FDA.report

Premio E250

Primary DI
00815871020541
Brand
Premio E250
Company
Avante
Model
7JVIPRS
Published
2016-09-23
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
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815871020541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871020541008158710205418158710205410815871020541

GMDN Terms

TermDefinition
Basic electric hospital bedA mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.

Sterilization Methods

Method

Contacts

PhoneEmail
502-244-4444devicehelp@dremed.com

Regulatory Flags

DUNS number
178440426
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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00815871020220Compact FM60130TD2016-09-23
00815871020237Compact Plus601312016-09-23
00815871020244Compact Plus60131EXP2016-09-23
00815871020251Compact Plus60131B2016-09-23
00815871020268Compact Plus60131EXP22016-09-23
00815871020275Compact Plus60131I2016-09-23
00815871020282Compact Plus60131EXPI2016-09-23
00815871020343DM-66070130P2016-09-23
00815871020350DM-66070130PE2016-09-23
00815871020909Waveline EZ+601442016-09-23
00815871020916Waveline EZ+60144CO22016-09-23
00815871020923Waveline EZ+60144CO2S2016-09-23
00815871020930Waveline EZ+60144IBP2016-09-23
00815871020947Waveline EZ+60144NP2016-09-23
00815871020954Waveline EZ+60144TIBP2016-09-23
00815871020961Waveline EZ+60144TNIBP2016-09-23

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