Jelco

GUDID 55019315118546

SMITHS MEDICAL GROUP LTD

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: 55019315118546
• NIH Device Record Key: ea309578-be8a-42d6-aa2e-a4876b7d2848
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jelco
• Version Model Number: 446611
• Company DUNS: 738829485
• Company Name: SMITHS MEDICAL GROUP LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019315118548 [Primary]
GS1	35019315118542 [Package]; Contains: 15019315118548; Package: BOX [50 Units]; In Commercial Distribution
GS1	55019315118546 [Package]; Contains: 35019315118542; Package: CARTON [200 Units]; In Commercial Distribution

FDA Product Code

• FOZ: Catheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-10-05

On-Brand Devices [Jelco]

• 35019315118665: 508811
• 55019315118652: 508211
• 55019315118645: 505711
• 55019315118638: 505611
• 55019315118621: 505511
• 55019315118614: 505311
• 55019315118607: 505011
• 35019315118597: 504811
• 35019315118580: 504211
• 35019315118573: 448811
• 55019315118553: 446711
• 55019315118546: 446611
• 35019315118535: 446511
• 35019315118528: 446411
• 35019315118511: 446111
• 55019315118492: 449211
• 55019315118485: 442711
• 55019315118478: 442611
• 55019315118461: 442511
• 35019315118450: 442411
• 55019315118447: 442011
• 55019315118430: 441811
• 55019315118423: 441211
• 35019315118399: 405911
• 35019315118382: 405711
• 55019315118379: 405611
• 35019315118368: 405511
• 55019315118355: 405411
• 55019315118348: 405311
• 55019315118331: 405011
• 35019315118320: 404811
• 55019315118317: 404211
• 55019315118560: 448211
• 55019315118508: 449811
• 35019315118412: 408811
• 55019315118409: 408211