Jelco

GUDID 55019315118553

SMITHS MEDICAL GROUP LTD

Peripheral vascular infusion catheter

• Primary Device ID: 55019315118553
• NIH Device Record Key: 41197d96-1d4a-455e-bba1-87761affa0f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jelco
• Version Model Number: 446711
• 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	15019315118555 [Primary]
GS1	35019315118559 [Package]; Contains: 15019315118555; Package: BOX [50 Units]; In Commercial Distribution
GS1	55019315118553 [Package]; Contains: 35019315118559; 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