Peritoneal Dialysis Catheter SI-1231

GUDID 00792079000141

Medionics International Inc

Peritoneal dialysis catheter, acute/chronic

• Primary Device ID: 00792079000141
• NIH Device Record Key: ada03d3e-5260-4c96-a3ac-d7b9151c947f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peritoneal Dialysis Catheter
• Version Model Number: SI-1231
• Catalog Number: SI-1231
• Company DUNS: 241421320
• Company Name: Medionics International Inc
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792079000141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993149

FDA Product Code

• FJS: Catheter, Peritoneal, Long-Term Indwelling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-17

On-Brand Devices [Peritoneal Dialysis Catheter]

• 00792079001674: SA-1255
• 00792079001476: PSNA-100
• 00792079000967: SNCA-5263LFD
• 00792079000592: SNPS-53113
• 00792079000363: SNCP-5243L
• 00792079000356: SNCA-5262L
• 00792079000264: CP-1241
• 00792079000226: CA-1157
• 00792079000219: CA-1162
• 00792079000196: CA-2262
• 00792079000141: SI-1231
• 00792079000035: SA-1248K
• 00792079000028: SA-1247