FDA.report

VentStar Watert. 180 w/o LuerL

Primary DI
04048675126447
Brand
VentStar Watert. 180 w/o LuerL
Company
Drägerwerk AG & Co. KGaA
Model
MP00334
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
BYHDrain, Tee (Water Trap)

Product Code Classifications

CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675126447PrimaryGS10
04048675422181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675126447040486751264474048675126447
04048675422181040486754221814048675422181

GMDN Terms

TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820info@draeger.com

Regulatory Flags

DUNS number
315578914
Device count
25
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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