DEVICE: Resp-O2 Small Volume Nebulizer 6 cc Cup (00840117311916)

Device Identifier (DI) Information

Resp-O2 Small Volume Nebulizer 6 cc Cup
34107
In Commercial Distribution

Dynarex Corporation
00840117311916
GS1

1
008124539 *Terms of Use
7' (2.1m) Tubing, Standard Connector, 45 Degrees Pacifier Elbow, Infant/Toddler
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Device Characteristics

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

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62042 Nebulizing system delivery set, reusable
A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.
Active false
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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 [?]
K150591 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

8b4c84fe-5daf-451c-9bd1-b123b6968779
October 09, 2024
3
April 22, 2021
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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
00840117317994 12 00840117311916 In Commercial Distribution Box
00840117311923 12 00840117317994 In Commercial Distribution Shipper
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
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Customer Contact

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No Customer Contact currently defined
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