FDA.report

ErgoStar CM 60

Primary DI
04048675042662
Brand
ErgoStar CM 60
Company
Drägerwerk AG & Co. KGaA
Model
MP01860
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675042662PrimaryGS10
04048675420699Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675042662040486750426624048675042662
04048675420699040486754206994048675420699

GMDN Terms

TermDefinition
Tube/mask breathing circuit connector, single-use, non-sterileA non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with standardized 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 (excluding 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820info@draeger.com

Regulatory Flags

DUNS number
315578914
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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