Primary Device ID | 10813623015378 |
NIH Device Record Key | ceab0a96-f227-45f0-8ab3-9cc33c7c0351 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASEPT Peritoneal Drainage System |
Version Model Number | M7000 |
Catalog Number | M7000 |
Company DUNS | 097736867 |
Company Name | PFM MEDICAL INCORPORATED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 7607588749 |
regulatory@pfmmedicalusa.com | |
Phone | 7607588749 |
regulatory@pfmmedicalusa.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813623015371 [Primary] |
GS1 | 10813623015378 [Package] Contains: 00813623015371 Package: [10 Units] In Commercial Distribution |
KDQ | Bottle, Collection, Vacuum |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-09-06 |
Device Publish Date | 2015-10-15 |
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10813623015378 | ASEPT 1,000mL Drainage Kit |
10813623014227 | ASEPT Drainage Bag with Procedure Pack |
10813623011158 | ASEPT Peritoneal Drainage System |
10813623011141 | ASEPT 1,000mL Drainage Kit |
20813623011117 | ASEPT Vented Lock Cap |