FDA.report

Infinity ID WaterLock2

Primary DI
04048675249351
Brand
Infinity ID WaterLock2
Company
Drägerwerk AG & Co. KGaA
Model
6872020
Published
2017-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04048675249351PrimaryGS10
04048675425557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675249351040486752493514048675249351
04048675425557040486754255574048675425557

GMDN Terms

TermDefinition
Breathing circuit condensate trap, reusableA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820INFO@DRAEGER.COM

Regulatory Flags

DUNS number
315578914
Device count
12
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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