DEVICE: ACCLARENT BALLOON INFLATION DEVICE (10705031063570)

Device Identifier (DI) Information

ACCLARENT BALLOON INFLATION DEVICE
BID30
In Commercial Distribution
BID30
ACCLARENT, INC.
10705031063570
GS1

1
361092450 *Terms of Use
ACCLARENT INFLATION DEVICE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Catheter-balloon inflator, single-use A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. It typically consists of a dedicated syringe/plunger mechanism, a gauge or integral pressure transducer for monitoring pressure within the balloon, a locking mechanism, and a connecting tube. It may also be used to inflate the balloon of an inflatable balloon tamp or an endomicroscopy probe. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LRC INSTRUMENT, ENT MANUAL SURGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052198 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

83094983-15f3-4beb-9535-b2b433714325
July 06, 2018
3
October 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30705031063574 5 10705031063570 In Commercial Distribution BOX
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+1(877)775-2789
xx@xx.xx
+1(650)687-5888
xx@xx.xx
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