FDA.report

Resp-O2 Aerosol Drainage Bag

Primary DI
00840117311985
Brand
Resp-O2 Aerosol Drainage Bag
Company
DYNAREX CORPORATION
Model
34200
Device description
Resp-O2Aerosol Drainage Bag w/ Y-Adaptor; 750cc, Accepts Standard 22mm ID corrugated tubing
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00840117311985PackageGS150In Commercial Distribution
00840117311978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117311985008401173119858401173119850840117311985
00840117311978008401173119788401173119780840117311978

GMDN Terms

TermDefinition
Thermal vapour lung treatment system drainage bagA non-sterile plastic pouch intended to collect the effluent (water) from a thermal vapour lung treatment system generator after the water vapour has cooled and condensed. It typically has tabs for attachment to the generator trolley. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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