DEVICE: Argyle (10884527007103)
Device Identifier (DI) Information
Argyle
8888163030
In Commercial Distribution
8888163030
Cardinal Health, Inc.
8888163030
In Commercial Distribution
8888163030
Cardinal Health, Inc.
CPAP Nasal Cannula with Bonnet,Babies 1000 g >1500 g
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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? |
---|---|---|---|---|
35202 | Nasal oxygen cannula, CPAP |
A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K811409 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: ; |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Clothing Size,Small,N/A; |
Device Record Status
038c64a9-c0d2-42c7-a081-26c48dc9da70
February 27, 2025
8
September 24, 2016
February 27, 2025
8
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884527007100 | 10 | 10884527007103 | 2026-12-31 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined