DEVICE: Curaplex (00812277038224)
Device Identifier (DI) Information
Curaplex
301-PASC107
In Commercial Distribution
301-PASC107
BOUND TREE MEDICAL, LLC
301-PASC107
In Commercial Distribution
301-PASC107
BOUND TREE MEDICAL, LLC
O2 DELIVERY KIT, PACU 50/CA
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
12855 | Oxygen administration kit, sterile |
A collection of sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, and connectors. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BYG | MASK, OXYGEN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
10156d40-d6bd-40b1-b9f7-0dd92b949be7
January 09, 2023
1
December 30, 2022
January 09, 2023
1
December 30, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00810071630361 | 3 | 00812277039481 | In Commercial Distribution | CS | |
00812277039481 | 20 | 00812277038224 | In Commercial Distribution | BX |
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