FDA.reportPublic FDA data

Ave 2

Primary DI
08592654426142
Brand
Ave 2
Company
L I N E T spol. s r.o.
Model
1PPBA4-619
Device description
Electrical birthing bed
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HDDTable, Obstetrical, Ac-Powered (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDDTable, Obstetrical, Ac-Powered (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592654426142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592654426142085926544261428592654426142

GMDN Terms#

Term, Definition table
TermDefinition
Birthing bed/table, poweredAn electrically-powered, adjustable device designed to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair, and will typically include, leg holders (stirrups), traction handles, a receptacle for afterbirth, and have facilities for the attachment of different accessories.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
644544504
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592654601235Sprint 2001ES200-1702026-05-11
08592654577462Eleganza 51GE512055-28372026-02-26
08592654578445Sprint 4001ES410-282026-02-26
08592654582992Eleganza 51GE512055-25972026-02-26
08592654544112OPTICARE1VSM-52026-01-07
08592654554524Sprint 1001ES105308-9742026-01-07
08592654562703Multicare X1MCX12050-9372026-01-07
08592654569405Eleganza 51GE512055-25952026-01-07
08592654550441Multicare1MC17350-23922025-12-22
08592654552889Eleganza 51GE512055-26772025-12-22
08592654556184Sprint 2001ES410-32025-12-22
08592654851067Ergozone 3000EZ3-SEN 2025-11-03
08592654851074Ergozone 3000EZ3-SENXL2025-11-03
08592654851081Ergozone 3000EZ3-SXXL 2025-11-03
08592654525883Sprint 2001ES400-52025-10-02
08592654542163Sprint 2001ES200-5212025-10-02
08592654542811Sprint 2001ES210-2102025-10-02
08592654542835Sprint 2001ES211-3092025-10-02
08592654851036Ergozone 3000EZ3-EMCX2025-06-24
08592654851043Ergozone 5000EZ5-EMCX2025-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654444726VibwifeL I N E T spol. s r.o.HDD2024-10-23
08592654463659Ave 2L I N E T spol. s r.o.HDD2024-10-23
08592654455562Ave 2L I N E T spol. s r.o.HDD2024-06-20
08592654435540VibwifeL I N E T spol. s r.o.HDD2024-04-03
08592654422298Ave 2L I N E T spol. s r.o.HDD2023-12-11
08592654397657Ave 2L I N E T spol. s r.o.HDD2023-05-05
08592654399682Ave 2L I N E T spol. s r.o.HDD2023-05-05
08592654801116Ave 2L I N E T spol. s r.o.HDD2022-04-14
08592654801079Ave 2L I N E T spol. s r.o.HDD2022-02-02
08592654801086Ave 2L I N E T spol. s r.o.HDD2022-02-02
08592654801055Ave 2L I N E T spol. s r.o.HDD2021-12-09
08592654801031Ave 2L I N E T spol. s r.o.HDD2021-05-14
08592654800966Ave 2L I N E T spol. s r.o.HDD2020-12-21
08592654801017Ave 2L I N E T spol. s r.o.HDD2020-12-21
08592654801024Ave 2L I N E T spol. s r.o.HDD2020-12-21
08592654800812AVE 2L I N E T spol. s r.o.HDD2020-05-22
08592654800829Ave 2L I N E T spol. s r.o.HDD2020-05-22
08592654800959Ave 2L I N E T spol. s r.o.HDD2020-05-22
08596307100014Ave 2L I N E T spol. s r.o.HDD2019-10-01
08592654800249Ave 2L I N E T spol. s r.o.HDD2019-06-07
08592654800188Ave 2L I N E T spol. s r.o.HDD2019-06-05
08592654800065Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800072Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800089Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800096Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800102Ave 2L I N E T spol. s r.o.HDD2018-04-10
07613327175165NASTRYKER CORPORATIONHDD2016-09-24
07613327175172NASTRYKER CORPORATIONHDD2016-09-24
07613327175189NASTRYKER CORPORATIONHDD2016-09-24
07613327175196NASTRYKER CORPORATIONHDD2016-09-24