DEVICE: SafetyNeb (00817494020694)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
SafetyNeb
AM-NEB-FP
In Commercial Distribution

GROMAN INC.
00817494020694
GS1
March 01, 2123
1
020124663 *Terms of Use
One Kit of SafetyNeb Mask with FacePlate and Nebulizer Tubing
CLOSE

Device Characteristics
MR Safe
No
Yes
Yes
No
No
Yes
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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BYF Mask, Oxygen, Low Concentration, Venturi
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
fc9ef63f-bf71-4321-b44a-d4624082e31d
March 09, 2023
1
March 01, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10817494020691 25 00817494020694 2123-03-01 In Commercial Distribution Box
20817494020698 50 00817494020694 2123-03-01 In Commercial Distribution Box
30817494020695 100 00817494020694 2123-03-01 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE