FDA.report

FLEXIBLE DOUBLE SWIVEL CATHETER MOUNT 22F-DOUBLE FLIP TOP CAP WITH SEAL

Primary DI
05030267083992
Brand
FLEXIBLE DOUBLE SWIVEL CATHETER MOUNT 22F-DOUBLE FLIP TOP CAP WITH SEAL
Company
INTERSURGICAL INCORPORATED
Model
3505000
Device description
FLEXIBLE DOUBLE SWIVEL CATHETER MOUNT 22F - DOUBLE FLIP TOP CAP WITH SEAL - 22M/15F >= 170MM
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
05030267083992PackageGS150In Commercial Distribution
05030267065875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267083992050302670839925030267083992
05030267065875050302670658755030267065875

GMDN Terms

TermDefinition
Breathing circuit catheter mount, single-useA device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end which may have a suction port included. 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
true
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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