Primary Device ID | 00817081028256 |
NIH Device Record Key | e6d7a439-f05e-4611-a3e2-aa9f568e4c66 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue Depressing |
Version Model Number | Breathebite Mouthpiece - 164954 |
Catalog Number | 164954 |
Company DUNS | 020275145 |
Company Name | A-M SYSTEMS, LLC |
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 | 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 |
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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 | 2025-03-03Breathebite Mouthpiece, Disposable, White, Thermoplastic, Tongue Depressing, 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 |