FDA.report

Jelco

Primary DI
30351688072065
Brand
Jelco
Company
SMITHS MEDICAL ASD, INC.
Model
407600
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30351688072065PackageGS1200In Commercial Distribution
50351688072069PackageGS14In Commercial Distribution
10351688072061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3035168807206530351688072065
5035168807206950351688072069
1035168807206110351688072061

GMDN Terms

TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
146235697
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10887709142029BivonaST24LN70ZSZ142N2025-02-11
10887709141459BivonaFU24LN35NGF086N2025-01-28
10887709139654BivonaZT24KN80NSC005N2025-01-22
10887709136912BivonaZU24JN80NSC259N2025-01-09
10887709141848BivonaST24LN85NSZ127N2025-01-07
10887709142111BivonaZU24LN40NGF133N2025-01-07
10887709142135BivonaFU24LN50NSZ146N2025-01-07
10887709142234BivonaZU24LN30NSE161N2025-01-07
10887709142241BivonaFT24LN50NGC163N2024-12-19
10887709142258BivonaFU24LN40NSA164N2024-12-19
10887709142265BivonaSU24LN60NSB165N2024-12-19
10887709142272BivonaFU24LN35NSF168N2024-12-19
10887709142289BivonaFT24LN55NSF169N2024-12-19
10887709142296BivonaFT24LN40NSE170N2024-12-19
10887709142302BivonaHT24LS55NSA171N2024-12-19
10887709142319BivonaST24LN90NSC124S2024-12-19
10887709142326BivonaFT24LN40NSE166N2024-12-19
10887709142333BivonaSU24LN40NSB167N2024-12-19
10887709142340BivonaHF24LS90NSB174N2024-12-19
10887709142357BivonaFT24LN55NGF172N2024-12-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20801902219385ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30801902219405ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219415ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219460ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219484ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219514ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30197344181517MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344181527MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344199690MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20801902225478ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225485ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225492ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225539ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
30801902219375ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219392ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219422ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219439ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219446ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219453ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219477ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219491ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219507ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219521ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219538ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219545ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219569ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219576ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219583ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219590ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
30382903836483NexivaBECTON, DICKINSON AND COMPANYFOZ2026-02-17