LMA 131080

GUDID 35060112310486

LMA Fastrach™ ETT 8.0mm

TELEFLEX INCORPORATED

Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use

Primary Device ID	35060112310486
NIH Device Record Key	1827958e-596c-4023-a7ce-03c2f02f85a9
Commercial Distribution Status	In Commercial Distribution
Brand Name	LMA
Version Model Number	IPN042401
Catalog Number	131080
Company DUNS	002348191
Company Name	TELEFLEX INCORPORATED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0
Lumen/Inner Diameter	8 Millimeter
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Dark cool environment avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060112310485 [Primary]
GS1	15060112310482 [Package] Contains: 05060112310485 Package: Box [10 Units] In Commercial Distribution
GS1	25060112310489 [Package] Contains: 15060112310482 Package: Carton [10 Units] In Commercial Distribution
GS1	35060112310486 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991580

FDA Product Code

BTR	Tube, tracheal (w/wo connector)