ACCLARENT BALLOON INFLATION DEVICE BID30

GUDID 30705031063574

ACCLARENT INFLATION DEVICE

ACCLARENT, INC.

Catheter/overtube balloon inflator, single-use

Primary Device ID	30705031063574
NIH Device Record Key	83094983-15f3-4beb-9535-b2b433714325
Commercial Distribution Status	In Commercial Distribution
Brand Name	ACCLARENT BALLOON INFLATION DEVICE
Version Model Number	BID30
Catalog Number	BID30
Company DUNS	361092450
Company Name	ACCLARENT, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(877)775-2789
Email	xx@xx.xx
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031063570 [Primary]
GS1	30705031063574 [Package] Contains: 10705031063570 Package: BOX [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K052198

FDA Product Code

LRC	INSTRUMENT, ENT MANUAL SURGICAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2020-05-06
Device Publish Date	2016-10-01

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