DEVICE: Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask (00084530060800)

Device Identifier (DI) Information

Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask
RES092
In Commercial Distribution
RES092
SUNSET HEALTHCARE SOLUTIONS, INC.
00084530060800
GS1

1
141668116 *Terms of Use
Pediatric Nebulizer Kit - Disposable - w/ Jet Nebulizer, Pediatric Aerosol Mask, 7ft O2 tube - 50/cs
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Nebulizing system delivery set, single-use A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
CAF Nebulizer (Direct Patient Interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Pediatric
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Device Record Status

4878e4b0-59ac-473a-849c-448f66038482
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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

[?]
877-578-6738
customerservice@sunsethcs.com
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