DEVICE: PENDING (10884389966396)
Device Identifier (DI) Information
PENDING
HCSU4600B
In Commercial Distribution
HCSU4600B
MEDLINE INDUSTRIES, INC.
HCSU4600B
In Commercial Distribution
HCSU4600B
MEDLINE INDUSTRIES, INC.
MASK,OXYGEN,MED CONC,ADLT,7' TUB, UC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
35142 | Aerosol face mask, rebreathing, single-use |
A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.
|
Active | 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 |
---|
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ed78e2d0-b728-4fe4-b2f2-d05f535e4c23
April 19, 2022
1
April 11, 2022
April 19, 2022
1
April 11, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(800)633-5463
service@medline.com
service@medline.com