DEVICE: APack Mini L,CS Mask Stan5 (04048675420941)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
APack Mini L,CS Mask Stan5
MP01686
Not in Commercial Distribution
Drägerwerk AG & Co. KGaA
MP01686
Not in Commercial Distribution
Drägerwerk AG & Co. KGaA
No description.
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| Yes | |
| No | |
| 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? |
|---|---|---|---|---|
| 61346 | Straight/elbow breathing circuit connector, single-use |
A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.
|
Active | false |
| 60837 | Microbial medical gas filter, single-use |
A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.
|
Active | false |
| 36232 | Wheelchair tyre |
A circular cushion of rubber and/or synthetic material which is fitted to a wheelchair wheel rim and which functions as a soft contact to the surfaces upon which the wheelchair stands and provides the wheelchair with traction and some shock absorption as it is propelled. It comes in a variety of designs, diameters and sizes. This GMDN code is appropriate for spare and replacement tyres (tires).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
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
31c148f2-5ba0-4dbf-8a40-3088d0c0cf49
July 25, 2023
8
October 24, 2015
July 25, 2023
8
October 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 04048675252092 | 10 | 04048675420941 | 2015-12-31 | Not 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
[?]
+494518820
info@draeger.com
info@draeger.com