FDA.reportPublic FDA data

JMS WINGEATER APHERESIS NEEDLE SET

Primary DI
08888483005321
Brand
JMS WINGEATER APHERESIS NEEDLE SET
Company
JMS SINGAPORE PTE LTD
Model
820-5008-33
Device description
"WINGEATER APHERESIS 15GX11/4"" 30CM"
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
FIENeedle, Fistula
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIENeedle, FistulaGastroenterology, Urology2
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58888483005326PackageGS1250In Commercial Distribution
08888483005321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5888848300532658888483005326
08888483005321088884830053218888483005321

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system tubing setA collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge15Gauge

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

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