FDA.report

FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F

Primary DI
05030267019199
Brand
FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F
Company
INTERSURGICAL INCORPORATED
Model
3532000
Device description
FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F, 100MM
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

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267019182PackageGS125In Commercial Distribution
05030267019199PackageGS1100In Commercial Distribution
05030267066353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267019182050302670191825030267019182
05030267019199050302670191995030267019199
05030267066353050302670663535030267066353

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

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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