FDA.report

ADJUSTABLE Y-PIECE WITH SWIVEL NECK

Primary DI
05030267004201
Brand
ADJUSTABLE Y-PIECE WITH SWIVEL NECK
Company
INTERSURGICAL INCORPORATED
Model
1929000
Device description
ADJUSTABLE Y-PIECE WITH SWIVEL NECK
Published
2021-10-12
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
05030267004201PackageGS115In Commercial Distribution
05030267004218PackageGS160In Commercial Distribution
05030267056408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267004201050302670042015030267004201
05030267004218050302670042185030267004218
05030267056408050302670564085030267056408

GMDN Terms

TermDefinition
Y-piece breathing circuit connector, single-useA connecting device shaped in the form of a "Y" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is typically made of light plastic. 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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