INSPIRA AIR BC1640A

GUDID 20705031147741

INSPIRA AIR BALLOON DILATION SYSTEM 16x40

ACCLARENT, INC.

Bronchial balloon catheter
Primary Device ID20705031147741
NIH Device Record Key75c4adf7-f83e-4172-90b3-2c41a7a6bfe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSPIRA AIR
Version Model NumberBC1640A
Catalog NumberBC1640A
Company DUNS361092450
Company NameACCLARENT, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)775-2789
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031147744 [Primary]
GS120705031147741 [Package]
Contains: 10705031147744
Package: BOX [5 Units]
In Commercial Distribution

FDA Product Code

KTIBRONCHOSCOPE ACCESSORY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-22
Device Publish Date2016-09-01

On-Brand Devices [INSPIRA AIR]

20705031242682INSPIRA AIR BALLOON DILATION SYSTEM, 8.5X24MM - 1PK
20705031147710INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM - 1 PK
20705031147703INSPIRA AIR BALLOON DILATION SYSTEM, 12X40MM - 1 PK
20705031063171INSPIRA AIR BALLOON DILATION SYSTEM 14x40, 1 PK
20705031063157INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK
20705031063126INSPIRA AIR BALLOON DILATION SYSTEM 7x24, 1 PK
20705031063089INSPIRA AIR BALLOON DILATION SYSTEM 5x24, 1 PK
20705031206059INSPIRA AIR BALLOON DILATION SYSTEM 8.5x24
20705031147741INSPIRA AIR BALLOON DILATION SYSTEM 16x40
20705031147734INSPIRA AIR BALLOON DILATION SYSTEM 12x40
20705031132068INSPIRA AIR BALLOON DILATION SYSTEM 7x24
20705031131993INSPIRA AIR BALLOON DILATION SYSTEM 5x24
20705031063317INSPIRA AIR BALLOON DILATION SYSTEM 14x40
20705031063294INSPIRA AIR BALLOON DILATION SYSTEM 10x40

Trademark Results [INSPIRA AIR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSPIRA AIR
INSPIRA AIR
77799114 4103460 Live/Registered
Acclarent, Inc.
2009-08-06

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