FDA.report

Resp-O2 Oxygen Tubing Adaptors

Primary DI
00840117318588
Brand
Resp-O2 Oxygen Tubing Adaptors
Company
DYNAREX CORPORATION
Model
33306
Device description
Resp-O2 Oxygen Tubing Y-Adaptors
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
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117318588PackageGS110In Commercial Distribution
00840117318663PrimaryGS10
00840117319868Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318588008401173185888401173185880840117318588
00840117318663008401173186638401173186630840117318663
00840117319868008401173198688401173198680840117319868

GMDN Terms

TermDefinition
Inhalation-therapy adaptor, single-useA small connecting device, usually with a small channel, intended to join a sterile water pack or a sterile isotonic sodium chloride solution pack to an inhalation therapy device (e.g., humidifier, nebulizer, oxygen therapy delivery system). It may be used when the connection is compatible (e.g., when the inhalation therapy device and the sterile liquid pack are of the same manufacture) or when incompatible (e.g., different manufacture). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
50
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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