FDA.report

Paediatric / Neonatal Self-Sealing Water Trap For Breathing Systems 15mm Connect

Primary DI
05055788759898
Brand
Paediatric / Neonatal Self-Sealing Water Trap For Breathing Systems 15mm Connect
Company
FLEXICARE MEDICAL LIMITED
Model
020-650U
Published
2020-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYHDrain, Tee (Water Trap)

Product Code Classifications

CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788759898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788759898050557887598985055788759898

GMDN Terms

TermDefinition
Breathing circuit condensate trap, single-useA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator 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 fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
504406273
Device count
1
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
false
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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