PEP-S

GUDID 00744229100003

PEP-S Positive Expiratory Pressure System

PARI RESPIRATORY EQUIPMENT, INC.

Mechanical positive pressure airway secretion-clearing device
Primary Device ID00744229100003
NIH Device Record Key3f90d82a-3af2-4f0e-9316-31c4ddf4691e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEP-S
Version Model Number018F63
Company DUNS804736098
Company NamePARI RESPIRATORY EQUIPMENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100744229100003 [Package]
Contains: 00744229180128
Package: carton [12 Units]
In Commercial Distribution
GS100744229180128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSpirometer, Therapeutic (Incentive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-30

Devices Manufactured by PARI RESPIRATORY EQUIPMENT, INC.

00744229100850 - Vortex2024-05-08 Mask, VORTEX, Pediatric Small
00744229100867 - Vortex2024-05-08 Mask, VORTEX, Pediatric Medium
00744229510529 - Vortex2024-05-06 Vortex Nonelectrostatic Holding Chmbr
00744229510536 - Vortex2024-05-01 Vortex w Pediatric Mask Small
00744229510543 - Vortex2024-05-01 Vortex w Pediatric Mask Medium
00744229510512 - Vortex2024-05-01 Vortex Hospital Package
00744229510598 - Vortex2024-05-01 Vortex w Adult Mask
00744229230205 - LC Sprint Star2023-08-18 LC Sprint Star Neb Set

Trademark Results [PEP-S]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEP-S
PEP-S
74378158 1856477 Dead/Cancelled
AMERSHAM PHARMACIA BIOTECH AB
1993-04-12

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