LMA 136075

GUDID 25060112310588

LMA Fastrach™ SU ETT 7.5mm

TELEFLEX INCORPORATED

Laryngeal 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 ID25060112310588
NIH Device Record Key0cbaf812-273a-445f-855c-190343ff349d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLMA
Version Model NumberIPN042416
Catalog Number136075
Company DUNS002348191
Company NameTELEFLEX INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter7.5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060112310584 [Primary]
GS115060112310581 [Package]
Contains: 05060112310584
Package: Box [10 Units]
In Commercial Distribution
GS125060112310588 [Package]
Contains: 15060112310581
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, tracheal (w/wo connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

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