FDA.reportPublic FDA data

Resp-O2 Spring Loaded T-Adaptor 22 mm OD x 22 mm OD

Primary DI
00840117312159
Brand
Resp-O2 Spring Loaded T-Adaptor 22 mm OD x 22 mm OD
Company
Dynarex Corporation
Model
34500
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117312166PackageGS130In Commercial Distribution
00840117312159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117312166008401173121668401173121660840117312166
00840117312159008401173121598401173121590840117312159

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation-therapy adaptor, single-useA connecting device, usually with a small channel or tubing, intended to join a water/saline pack or a noninvasive ventilation respiratory unit to an inhalation therapy device (e.g., humidifier, vibrating mesh nebulizer, oxygen therapy delivery system). It may be used when the connection is compatible (e.g., when the connected devices are of the same manufacture) or when incompatible (e.g., different manufacture). This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

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00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
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