| Primary Device ID | 04961333244645 |
| NIH Device Record Key | 5724253c-6683-4663-8b10-a7ff1d2b2f19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHONATORY AERODYNAMIC SYSTEM |
| Version Model Number | 6450-JP |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333244645 [Primary] |
| KLX | Electroglottograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-26 |
| Device Publish Date | 2018-03-26 |
| 04961333245420 | v4.0 PAS WIN10 UPGRADE |
| 04961333244645 | NASOMETER II (JAPAN) |
| 04961333236565 | PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) |
| 04961333231522 | PAS MICROPHONE |
| 04961333231065 | 30 ADULT LARGE DISPOSABLE MASK |
| 04961333231058 | 30 ADULT MED. DISPOSABLE MASKS |
| 04961333231041 | 30 ADULT SMALL DISPOSABLE MASK |
| 04961333231034 | 30 PEDIATRIC DISPOSABLE MASKS |
| 04961333230624 | Phonatory Aerodynamic System for CSL, Model 4500 Users |
| 04961333230501 | Flowhead Tubes, Set of 8 |
| 04961333230136 | Pressure Port Tubes, 25 Qty |
| 04961333230129 | PAS Airflow Head-to-Mask Couplers |
| 04961333230112 | PAS Tubes, Pressure Screening |
| 04961333230105 | PAS Tubes, Cardboard |
| 04961333230099 | PAS Pediatric Mask & Adapter (Reusable) |
| 04961333230082 | PAS Mask and Adapter (Reusable) |
| 04961333230075 | PAS Airflow Head |
| 04961333229918 | PAS Tubes, Intraoral |
| 04961333229901 | Phonatory Aerodynamic System |
| 04961333247424 | PHONATORY AERODYNAMIC SYSTEM CE |