FDA.reportPublic FDA data

Premio E250

Primary DI
00815871021463
Brand
Premio E250
Company
Avante
Model
D248853
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815871021463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871021463008158710214638158710214630815871021463

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815871020091Disposable Monopolar Handswitching PencilP005072016-09-23
00815871020190Compact FM601302016-09-23
00815871020206Compact FM60130EXP2016-09-23
00815871020213Compact FM60130T2016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979878770084CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
06979878770091CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
06979878770107CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
06979878770114CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceINVACARE CORPORATIONFNL2026-03-02
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONFNL2026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONFNL2026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONFNL2026-02-27
08592654577462Eleganza 5L I N E T spol. s r.o.FNL2026-02-26
08592654582992Eleganza 5L I N E T spol. s r.o.FNL2026-02-26
00369771005615GeriGentleEQJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-02-09
00840828195942GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.FNL2026-02-05
00840828195959GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.FNL2026-02-05
00840828189897102,103 P37,BE & NURSE,CUSTOM LABELINGCURBELL MEDICAL PRODUCTS, INC.FNL2023-08-01
008408281884323701 P37,1TO1,STND,72",ALT. THUMBSCREWSCURBELL MEDICAL PRODUCTS, INC.FNL2023-02-27
008408281872063701 P37, NO 2,3,16,19,27,28,29,36, 96"CURBELL MEDICAL PRODUCTS, INC.FNL2022-12-02
008408281872133701 P37, NO PINS 16,19,28,29,36, 96"CURBELL MEDICAL PRODUCTS, INC.FNL2022-12-02
008408281863843701 P37,NO PINS 1,12,13,17,23,32, 12"CURBELL MEDICAL PRODUCTS, INC.FNL2022-07-06
008408281863223701 S37,N,N.INLK,BE,ONLY,90°,6"CURBELL MEDICAL PRODUCTS, INC.FNL2022-06-21
008408281853703701 P37,1TO1,STND,24",ALT. THUMBSCREWSCURBELL MEDICAL PRODUCTS, INC.FNL2022-01-06
008408281843973701 P37,NO PINS 16,19,28,29CURBELL MEDICAL PRODUCTS, INC.FNL2021-10-04
008408281829973701 P37,1TO1,STANDARD,90°,144"CURBELL MEDICAL PRODUCTS, INC.FNL2021-03-08
008408281811813701 P37,04,1 TO 1,STD,STKR,PVKEYCURBELL MEDICAL PRODUCTS, INC.FNL2020-09-28
00840828179638102,103 P37,BE & NURSECURBELL MEDICAL PRODUCTS, INC.FNL2020-04-02
008408281795601/8" P37,N,BE (TIP,BASE),INLINECURBELL MEDICAL PRODUCTS, INC.FNL2020-03-27
008408281795771802 P37,GE,BED EXIT,NURSE,BE(10&16)CURBELL MEDICAL PRODUCTS, INC.FNL2020-03-27
008408281772903701 S37,1TO1,STANDARD,NO SPEAKERCURBELL MEDICAL PRODUCTS, INC.FNL2020-01-23
00840828175258(2)103 INL P37,BE & NURSECURBELL MEDICAL PRODUCTS, INC.FNL2019-11-19
008408281739573701,102 P37 NC ONLY,BE 102CURBELL MEDICAL PRODUCTS, INC.FNL2019-08-08
008408281733221802 P3701,GE/DUKANE,BED EXIT,1 LIGHT,2 LED,BED EXIT (3&10),INTERLOCK 17CURBELL MEDICAL PRODUCTS, INC.FNL2019-05-15