FDA.reportPublic FDA data

JMS SYSLOC A.V.FISTULA NEEDLE SET

Primary DI
08888483005413
Brand
JMS SYSLOC A.V.FISTULA NEEDLE SET
Company
JMS SINGAPORE PTE LTD
Model
824-1602-33
Device description
"SYSLOC AVF 16GX11/4"" BE 30CM W/CLAMP"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58888483005418PackageGS1300In Commercial Distribution
08888483005413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5888848300541858888483005418
08888483005413088884830054138888483005413

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis needleA sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge16Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 (510) 888 9090shosoki@jmsna.net

Regulatory Flags#

DUNS number
595159278
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08888483007967JMS CAVEO A.V. Fistula Needle Set864-15142025-08-26
08888483005055JMS A.V.FISTULA NEEDLE SET820-14692016-09-23
08888483005062JMS A.V. FISTULA NEEDLE SET820-15642016-09-23
08888483005079JMS A.V. FISTULA NEEDLE SET820-15652016-09-23
08888483005086JMS A.V. FISTULA NEEDLE SET820-15902016-09-23
08888483005093JMS A.V. FISTULA NEEDLE SET820-16442016-09-23
08888483005109JMS A.V. FISTULA NEEDLE SET820-16482016-09-23
08888483005116JMS A.V. FISTULA NEEDLE SET820-17012016-09-23
08888483005123JMS A.V. FISTULA NEEDLE SET820-17342016-09-23
08888483005161JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)820-35002016-09-23
08888483005178JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)820-35072016-09-23
08888483005185JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)820-36002016-09-23
08888483005192JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)820-36052016-09-23
08888483005208JMS ROTATING HUB A.V.FISTULA NEEDLE SET823-15322016-09-23
08888483005215JMS ROTATING HUB A.V.FISTULA NEEDLE SET823-16352016-09-23
08888483005222JMS ROTATING HUB A.V.FISTULA NEEDLE SET823-17252016-09-23
08888483005239JMS WINGEATER A.V.FISTULA NEEDLE SET820-1476-332016-09-23
08888483005246JMS WINGEATER A.V.FISTULA NEEDLE SET820-1844-332016-09-23
08888483005253JMS WINGEATER A.V.FISTULA NEEDLE SET820-2402-332016-09-23
08888483005260JMS WINGEATER A.V.FISTULA NEEDLE SET820-2531-332016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
10801902102901ARROWTELEFLEX INCORPORATEDFOZ2019-12-10
10801902130331ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130355ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130379ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902133004ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133028ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133042ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133066ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133080ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133233ARROWTELEFLEX INCORPORATEDFOZ2017-03-08
10801902133127ARROWTELEFLEX INCORPORATEDFOZ2017-03-07
10801902132816ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902132823ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133097ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133103ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902131529ARROWTELEFLEX INCORPORATEDFOZ2017-02-17
10801902131512ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
10801902131567ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
00801741074769Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
00801741074783Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130935ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902129359ARROWTELEFLEX INCORPORATEDFOZ2016-11-11