DEVICE: Adapter, Plastic, 2" To 1624 Mouthpiece (00817081022988)
Device Identifier (DI) Information
Adapter, Plastic, 2" To 1624 Mouthpiece
Adapter, 2" To 1624 Mouthpiece - 114600
In Commercial Distribution
114600
A-M SYSTEMS, LLC
Adapter, 2" To 1624 Mouthpiece - 114600
In Commercial Distribution
114600
A-M SYSTEMS, LLC
Adapter, Tube, Blue Plastic, 2" To 1624 Mouthpiece 1 1/16" ID to 2" O.D.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 43467 | Breathing mouthpiece, reusable |
A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| BYP | Mouthpiece, Breathing |
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
a8bc1a24-06e2-4198-a42b-3298fcbbc05c
December 04, 2020
4
December 11, 2019
December 04, 2020
4
December 11, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 00817081022995 | 1 | 00817081022988 | In Commercial Distribution |
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
[?]
3606838300
sales@a-msystems.com
sales@a-msystems.com