FDA.report

Resp-O2 Oxygen Tubing Inline Water Traps

Primary DI
00840117318540
Brand
Resp-O2 Oxygen Tubing Inline Water Traps
Company
DYNAREX CORPORATION
Model
33302
Device description
Resp-O2 Oxygen Tubing Inline Water Traps
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
00840117318540PackageGS110In Commercial Distribution
00840117318625PrimaryGS10
00840117319820Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318540008401173185408401173185400840117318540
00840117318625008401173186258401173186250840117318625
00840117319820008401173198208401173198200840117319820

GMDN Terms

TermDefinition
In-line backflow valve, single-useA general-purpose device used in medical or laboratory tubing to prevent the backflow of gases or liquids. It will typically have a small ball or a leaf valve that instantly closes should a retrograde pressure (backflow) occur. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
10
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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