Primary Device ID | 00817081026726 |
NIH Device Record Key | 33a38c38-f268-4673-bbaf-02db74126faf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HydroMax HMEF |
Version Model Number | HydroMax HMEF - 158250 |
Catalog Number | 158250 |
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 | |
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 | |
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 | |
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 | |
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 | |
Phone | 3606838300 |
sales@a-msystems.com | |
Phone | 3606838300 |
sales@a-msystems.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817081026719 [Primary] |
GS1 | 00817081026726 [Package] Contains: 00817081026719 Package: [200 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 | 2020-07-16 |
Device Publish Date | 2020-07-08 |
00817081028270 - PFT Kit E, VBMax36E | 2025-03-05 Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton |
00817081028294 - Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton | 2025-03-05 Disposable White Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton |
00817081028317 - Disposable Blue PFT Nose Clip with Rubber Pads | 2025-03-05 Disposable Blue Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton |
00817081028331 - Disposable Blue PFT Nose Clip with Foam Pads | 2025-03-05 Disposable Blue PFT Nose Clip with Foam Pads, Labeled D R Burton |
00817081028232 - Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style | 2025-03-03 Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton |
00817081028256 - Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue Depressing | 2025-03-03 Breathebite Mouthpiece, Disposable, White, Thermoplastic, Tongue Depressing, D R Burton |
00817081028218 - PFT Nose Clip with Foam Pads | 2025-02-28 Disposable White Pulmonary Function Testing Nose Clip with Foam Pads |
00817081028195 - Pulmonary Function Test Kit E | 2025-02-26 Pulmonary Function Test Kit E, VBMax35E W/ Foam Nose Clip & 1649, Labeled D R Burton |