FDA.reportPublic FDA data

Tom 2

Primary DI
08592654433973
Brand
Tom 2
Company
L I N E T spol. s r.o.
Model
1K40B511-261
Device description
Pediatric hospital bed.
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMSBed, Pediatric Open Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMSBed, Pediatric Open HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592654433973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592654433973085926544339738592654433973

GMDN Terms#

Term, Definition table
TermDefinition
Paediatric bedA bed with appropriate size for children (typically up to 12 years of age) that incorporates safety canopy tops, fixed endrails, and moveable and latchable siderails. It allows children complete freedom in bed without the danger of falling out, yet allows staff access to the patient. Paediatric beds are not appropriate for neonates/infants.

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
07613327623284Double Tier Tray Outer ShellMAKO SURGICAL CORP.FMS2026-01-30
00850022426773C1983CGNOVUM MEDICAL PRODUCTS INCFMS2024-02-14
00850022426766C2080FWCRNOVUM MEDICAL PRODUCTS INCFMS2024-01-12
08592654351956Tom 2L I N E T spol. s r.o.FMS2023-12-11
08592654389690Tom 2L I N E T spol. s r.o.FMS2023-04-14
00850022426650C2083CGNOVUM MEDICAL PRODUCTS INCFMS2023-02-16
00850022426643C2072CLNOVUM MEDICAL PRODUCTS INCFMS2022-11-17
08592654376386Tom 2L I N E T spol. s r.o.FMS2022-11-16
00850022426636C1981CGTNOVUM MEDICAL PRODUCTS INCFMS2022-11-15
08592654289884Tom 2L I N E T spol. s r.o.FMS2022-04-29
08592654353882Tom 2L I N E T spol. s r.o.FMS2022-04-29
08592654348000Tom 2L I N E T spol. s r.o.FMS2022-02-28
08592654345450Tom 2L I N E T spol. s r.o.FMS2022-01-21
00850022426490C2081CLNOVUM MEDICAL PRODUCTS INCFMS2021-05-18
00850022426346E1981CL-3SDNOVUM MEDICAL PRODUCTS INCFMS2021-03-11
00850022426339C1970CLTNOVUM MEDICAL PRODUCTS INCFMS2021-03-08
00850022426315E2065FWCR-18UNOVUM MEDICAL PRODUCTS INCFMS2021-03-02
00850022426117C2081CGTNOVUM MEDICAL PRODUCTS INCFMS2021-01-26
07613327282702HAVASUSTRYKER CORPORATIONFMS2021-01-20
07613327282740HAVASUSTRYKER CORPORATIONFMS2021-01-20
00850925007802E2072CLTNOVUM MEDICAL PRODUCTS INCFMS2020-05-27
00850925007796E2092CGNOVUM MEDICAL PRODUCTS INCFMS2020-04-01
00850925007789E1982CG-CHNOVUM MEDICAL PRODUCTS INCFMS2020-03-25
00850925007765115E-H-ANOVUM MEDICAL PRODUCTS INCFMS2020-01-24
08592654210970Tom 2L I N E T spol. s r.o.FMS2019-11-07
00850925007758E1980FWCR-3SDNOVUM MEDICAL PRODUCTS INCFMS2019-10-29
00850925007741C2082CLTNOVUM MEDICAL PRODUCTS INCFMS2019-09-16
00850925007734C1970CLNOVUM MEDICAL PRODUCTS INCFMS2019-09-05
00850925007727E2083CGNOVUM MEDICAL PRODUCTS INCFMS2019-06-10
B751PDLFT0PediaLiftPEDIALIFT LLCFMS2019-05-07