Primary Device ID | 00817081028270 |
NIH Device Record Key | b9282933-6c23-490a-99e7-13d3fce21f23 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PFT Kit E, VBMax36E |
Version Model Number | PFT Kit E, VBMax36E - 189139 |
Catalog Number | 189139 |
Company DUNS | 020275145 |
Company Name | A-M SYSTEMS, LLC |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 3606838300 |
sales@a-msystems.com | |
Phone | 3606838300 |
sales@a-msystems.com | |
Phone | 3606838300 |
sales@a-msystems.com | |
Phone | 3606838300 |
sales@a-msystems.com | |
Phone | 3606838300 |
sales@a-msystems.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817081028263 [Primary] |
GS1 | 00817081028270 [Package] Contains: 00817081028263 Package: [100 Units] In Commercial Distribution |
CAH | Filter, Bacterial, Breathing-Circuit |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-05 |
Device Publish Date | 2025-02-25 |
00817081022629 | PFT Kit E, Disposable, Qty 100, VBMax36E, W/ Blue Foam Nose Clips |
00817081028270 | Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton |