FDA.reportPublic FDA data

MRVLS

Primary DI
07290102590018
Brand
MRVLS
Company
Elecam Medical Agricultural Cooperative Society Ltd.
Model
NA
Catalog number
572808
Device description
MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMGStopcock, I.V. Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060231000CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCKElcam Medical Acal2006-04-13FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290102590015PackageGS145Not in Commercial Distribution
27290102590012PackageGS16Not in Commercial Distribution
07290102590018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010259001517290102590015
2729010259001227290102590012
07290102590018072901025900187290102590018

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure200KiloPascal

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+97246988120sales@elcam.co.il

Regulatory Flags#

DUNS number
532599255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290102590216A-TAPNA5703132024-01-29
17290102590213A-TAPNA5703132024-01-29
07290102590025STP 4WAY RADNA5724882016-09-24
07290102590032STP 1 WAY RADNA5721102016-09-24
07290102590049STP LB GXL BLS RAD Large Bore Stopcock4560612020-06-01
07290102590056CSTP LB1V GXL BLS RADLarge Bore Closed stopcock4560662020-06-01
07290102590063CSTP LB 2V GXL BLSLarge Bore Closed Stopcock4560632020-06-01
07290102590070MRVLS LB1V GXL BLS RADLarge Bore MRVLS Stopcock4560642020-06-01
07290102590087MRVLS LB 2V GXL BLSLarge Bore MRVLS Stopcock4560652020-06-01
17290102590015MRVLSNA5728082016-09-24
27290102590029STP 4WAY RADNA5724882016-09-24
27290102590036STP 1 WAY RADNA5721102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
23700550400763Qitexio 4-Way StopcockMEDEXFMG2025-05-09
00382903949106Connecta, Luer-LokBD Switzerland SàrlFMG2023-09-21
00634624921092High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921108High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921160High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921191High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921245High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFMG2022-11-30
10193489896824Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMG2022-08-04
00840619006174ICU MedicalICU MEDICAL, INC.FMG2021-10-05
00840619006136ICU MedicalICU MEDICAL, INC.FMG2021-08-29
00840619005955ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006020ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006075ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006730ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023232ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023249ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023263ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023379ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619000028ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619000042ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001537ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001650ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001742ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001773ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00749756310734DeRoyalDEROYAL INDUSTRIES, INC.FMG2021-07-12
00634624911017Q2 High Flow StopcockQUEST MEDICAL INCFMG2021-05-12
10193489191684MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10193489191707MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10888439636703CARDINAL HEALTHCardinal Health 200, LLCFMG2019-12-17
10653160330936CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFMG2019-11-05