FDA.report

SHERIDAN

Primary DI
34026704760078
Brand
SHERIDAN
Company
TELEFLEX INCORPORATED
Model
IPN926918
Catalog number
5-15401
Device description
SHER-I-SWIV/FO
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSRSTYLET, TRACHEAL TUBE

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704760078PackageGS125In Commercial Distribution
14026704760074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670476007834026704760078
1402670476007414026704760074

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
Ethylene Oxide

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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