Kitabis Pak
Tobramycin
PARI RESPIRATORY EQUIPMENT, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2954963 | 1000142942 | PARI RESPIRATORY EQUIPMENT, INC. | 1 | N | 2026-01-01 | 2412 PARI Way MIDLOTHIAN VA US 23112 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 47291 | 1462128162 | K982334 | AIRZONE PEAK FLOWMETER | BZH | 1999-01-14 |
| 47291 | 1961115411 | K972042 | PARI PEP THERAPY SYSTEM | BWF | 1997-08-05 |
| 47291 | 1115140998 | K963924 | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 | CAF | 1996-12-10 |
| 47291 | 1576355291 | K944152 | PARI BABY | CAF | 1994-11-18 |
| 47291 | 1838282449 | K935540 | PARI-MASTER MODIFICATION | CAF | 1995-03-17 |
| 47291 | 1093142635 | K926455 | PARI FILTER/VALVE SET | CAF | 1993-09-28 |
| 47291 | 1586633984 | K191270 | Proneb Max | CAF | 2020-01-23 |
| 47291 | 1632281353 | K150044 | O-PEP | BWF | 2016-05-27 |
| 47291 | 1134030357 | K112859 | ERAPID NEBULIZER SYSTEM | CAF | 2012-05-30 |
| 47291 | 1111826245 | K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | CAF | 2010-02-22 |
| 47291 | 1645297102 | K092918 | PARI VIOS | CAF | 2010-02-04 |
| 47291 | 1583939477 | K092560 | PARI SINUS | CAF | 2010-05-06 |
| 47291 | 1621045142 | K090829 | PARI PEP S | BWF | 2009-07-21 |
| 47291 | 2010870783 | K070498 | HYPER SAL | CAF | 2007-04-26 |
| 47291 | 1461919906 | K062158 | LC SPRINT STAR | CAF | 2006-08-28 |
| 47291 | 1114255950 | K061381 | LC STAR WITH NASAL ADAPTER | CAF | 2006-06-02 |
| 47291 | 1021189048 | K060399 | LC SPRINT NEBULIZER | CAF | 2006-03-02 |
| 47291 | 1985068206 | K060357 | TREK S NEBULIZER COMPRESSOR | CAF | 2006-04-05 |
| 47291 | 1984557683 | K033833 | EFLOW ELECTRONIC INHALER/NEBULIZER | CAF | 2004-05-05 |
| 47291 | 1589194320 | K020944 | VORTEX VALVED HOLDING CHAMBER | CAF | 2002-05-09 |
| 47291 | 1870776110 | K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | BTI | 2001-03-13 |
| 47291 | 1064041673 | ||||
| 47291 | 2070265175 | ||||
| 47291 | 1068448527 | ||||
| 47291 | 1127818664 | ||||
| 47291 | 1353197148 | ||||
| 47291 | 1518513962 | ||||
| 47291 | 2017100803 |
Product Codes Associated With Registrations#
NDC#
PMN#
eRapid Nebulizer System
Pari Respiratory Equipment, Inc.
Proneb Max
PARI Respiratory Equipment, Inc.
Velox Nebulizer System
PARI Respiratory Equipment, Inc.
O-PEP
PARI RESPIRATORY EQUIPMENT, INC.
ERAPID NEBULIZER SYSTEM
PARI RESPIRATORY EQUIPMENT, INC.
PARI SINUS
PARI RESPIRATORY EQUIPMENT, INC.
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
PARI RESPIRATORY EQUIPMENT, INC.
PARI VIOS
PARI RESPIRATORY EQUIPMENT, INC.
PARI PEP S
PARI RESPIRATORY EQUIPMENT, INC.
GUDID#
Adult Aerosol Mask - 044F7252
2025-03-21
Vortex - Mask, VORTEX, Pediatric Small
2024-04-30
Vortex - Mask, VORTEX, Pediatric Medium
2024-04-30
Vortex - Mask, VORTEX, Pediatric Small
2024-04-30
Vortex - Mask, VORTEX, Pediatric Medium
2024-04-30
Vortex - Vortex Nonelectrostatic Holding Chmbr
2024-04-26
Vortex - Vortex Nonelectrostatic Holding Chmbr
2024-04-26
Vortex - Vortex w Pediatric Mask Small
2024-04-23
Vortex - Vortex w Pediatric Mask Medium
2024-04-23
Vortex - Vortex Hospital Package
2024-04-23
Vortex - Vortex w Adult Mask
2024-04-23
Vortex - Vortex w Pediatric Mask Small
2024-04-23
Vortex - Vortex w Pediatric Mask Medium
2024-04-23
Vortex - Vortex Hospital Package
2024-04-23
Vortex - Vortex w Adult Mask
2024-04-23
LC Sprint Star - LC Sprint Star Neb Set
2023-08-10
Wing Tip - Tubing, Wing Tip, Safety Core
2023-06-28
Proneb Max - Proneb Max, 5 Yr, LC Sprint
2020-05-22
Proneb Max - Proneb Max, 5 Yr, LC Sprint
2020-05-22
Bubbles - Bubbles Pediatric Aerosol Mask
2023-04-13
Trek S - Battery, Replacement, Trek S
2016-10-05
PEP-S - PEP-S Positive Expiratory Pressure System
2016-09-30
O-PEP - PARI O-PEP System
2017-06-30
LC - Nose Clip
2016-11-17
Proneb Max - Replacement Filter, Proneb Max
2020-07-24
Proneb Max - Replacement Filter, 2 Pack, Proneb Max
2020-06-05
Proneb Max - Replacement Filter, 12 Pack, Proneb Max
2020-06-05
Proneb Max - Proneb Max, 5 Yr, LC Plus
2020-05-22
LC Plus - PARI LC Plus, Nebulizer Set, PRO
2020-04-07
LC Sprint - PARI LC Sprint, Nebulizer Set, PRO
2020-04-07
LC Plus - PARI LC Plus, Nebulizer Set, PRO
2020-04-07
LC Sprint - PARI LC Sprint, Nebulizer Set, PRO
2020-04-07
Lamira - Lamira Nebulizer System
2019-01-08
Lamira - Lamira Nebulizer Handset
2019-01-08
Lamira - Lamira Nebulizer Aerosol Head
2019-01-08
Lamira - Lamira Nebulizer System
2019-01-08
Lamira - Lamira Nebulizer Handset
2019-01-08
Lamira - Lamira Nebulizer Aerosol Head
2019-01-08
LC - Mouthpiece, LC Neb, Standard
2016-11-17
eRapid - eRapid Nebulizer System
2016-09-26