DEVICE: Mask ClassicStar,NIV,SE,S (04048675041115)

Device Identifier (DI) Information

Mask ClassicStar,NIV,SE,S
MP01573
In Commercial Distribution

Drägerwerk AG & Co. KGaA
04048675041115
GS1

1
315578914 *Terms of Use
No description.
CLOSE

Device Characteristics

MR Unsafe
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rebreathing oxygen face mask A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is typically non-sterile, non-conductive, and is available in a range of sizes. It is made of high-grade resins and/or other materials that produce a soft, flexible mask that will create an airtight seal against the patient's face. The device may include a headstrap and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CBK Ventilator, Continuous, Facility Use
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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

fa24239c-bec7-41d7-bac9-c10dd3552c14
March 29, 2018
2
October 24, 2015
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
No Package DIs found
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
No
Yes
No CLOSE

Customer Contact

[?]
+494518820
info@draeger.com
CLOSE