FDA.report

STRAIGHT SWIVEL 22M-22M/15F CO2 LEAK PORT, 7.6MM PORT

Primary DI
05030267100811
Brand
STRAIGHT SWIVEL 22M-22M/15F CO2 LEAK PORT, 7.6MM PORT
Company
INTERSURGICAL INCORPORATED
Model
5807000
Device description
STRAIGHT SWIVEL 22M-22M/15F CO2 LEAK PORT, 7.6MM PORT
Published
2021-10-15
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

Contact Domains

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267100804PackageGS125In Commercial Distribution
05030267100811PackageGS1100In Commercial Distribution
05030267070572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267100804050302671008045030267100804
05030267100811050302671008115030267100811
05030267070572050302670705725030267070572

GMDN Terms

TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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