DEVICE: MASK - OC Advanced (00383730001128)

Device Identifier (DI) Information

MASK - OC Advanced
00
In Commercial Distribution
HS81111
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00383730001128
GS1

1
220018415 *Terms of Use
OC Advanced Pediatric Small Mask
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Medicine chamber spacer, reusable A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
CAF NEBULIZER (DIRECT PATIENT INTERFACE)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K962822 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

cbc826d2-cbc7-4b95-a46e-a83cb35fba73
July 06, 2018
3
August 24, 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
No Package DIs found
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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

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(724)744-2500
respironics.service@philips.com
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