FDA.reportPublic FDA data

CUB

Primary DI
07613327169348
Brand
CUB
Company
STRYKER CORPORATION
Model
FL19H
Catalog number
FL19H
Published
2016-09-24
Public version status
Update
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
07613327169348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327169348076133271693487613327169348

GMDN Terms#

Term, Definition table
TermDefinition
Newborn-infant bedA bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-22 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327631388N/A50275000005027-500-0002026-06-16
07613327631395N/A50275001005027-500-1002026-06-19
07613327632774N/A50275004005027-500-4002026-06-16
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327623284Double Tier Tray Outer ShellMAKO SURGICAL CORP.FMS2026-01-30
08592654433973Tom 2L I N E T spol. s r.o.FMS2024-02-23
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