LMA 136080

GUDID 15060112310598

LMA Fastrach™ SU ETT 8.0mm

TELEFLEX INCORPORATED

Laryngeal airway, single-use
Primary Device ID15060112310598
NIH Device Record Key4c5eef7a-f6c7-4f25-9816-a26c2dc17767
Commercial Distribution StatusIn Commercial Distribution
Brand NameLMA
Version Model NumberIPN042417
Catalog Number136080
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

Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0

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
GS105060112310591 [Primary]
GS115060112310598 [Package]
Contains: 05060112310591
Package: Box [10 Units]
In Commercial Distribution
GS125060112310595 [Package]
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

On-Brand Devices [LMA]

25060112312384ARROW AutoFuser Disposable Pain Control Pump
15060112313384LMA Supreme® Airway Plus Pack Size 2.5
15060112313377LMA Supreme® Airway Plus Pack Size 1.5
25060112313299Esophageal Intubation Detector - Bulb
25060112313282Esophageal Intubation Detector - Syringe
25060112313244Pediatric Laryngo-Tracheal Mucosal Atomization Device with 5ml Oral Syringe
15060112313230Pediatric Laryngo-Tracheal Mucosal Atomization Device with 5ml Syringe
25060112313220Pediatric Laryngo-Tracheal Mucosal Atomization Device without Syringe
25060112313213Laringo-Tracheal Mucosal Atomatization Device without Syringe
15060112313209Laringo-Tracheal Mucosal Atomatization Device without Syringe
25060112313183Laringo-Tracheal Mucosal Atomatization Device with 5ml Oral Syringe
25060112313176Laringo-Tracheal Mucosal Atomatization Device with 3ml Syringe
25060112312902ARROW AutoFuser Disposable Pain Control Pump
25060112312896ARROW AutoSelector Disposable Pain Control Pump
25060112312889ARROW AutoSelector Disposable Pain Control Pump
25060112312872ARROW AutoSelector Disposable Pain Control Pump
25060112312865ARROW AutoSelector Disposable Pain Control Pump
25060112312858ARROW AutoSelector Disposable Pain Control Pump
25060112312841ARROW AutoSelector Disposable Pain Control Pump
25060112312834ARROW AutoSelector Disposable Pain Control Pump
25060112312827ARROW AutoFuser Disposable Pain Control Pump
25060112312803ARROW AutoSelector Disposable Pain Control Pump
25060112312797ARROW AutoSelector Disposable Pain Control Pump
25060112312780ARROW AutoSelector Disposable Pain Control Pump
25060112312773ARROW AutoFuser Disposable Pain Control Pump
25060112312766ARROW AutoFuser Disposable Pain Control Pump
25060112312759ARROW AutoFuser Disposable Pain Control Pump
25060112312735ARROW AutoFuser Disposable Pain Control Pump
15060112312714AF550x2ML/H 2ML-60LO FH 5" SAT C,4"IN
25060112312704ARROW AutoFuser Disposable Pain Control Pump
25060112312674ARROW AutoFuser Disposable Pain Control Pump
25060112312667ARROW AutoFuser Disposable Pain Control Pump
15060112312646AF 275 x 5ML/H 2ML-60LO FH 5"SAT C,4"IN
15060112312639AF 275 x 5ML/H 2ML-60LO FH STD C,4"INAF
25060112312629ARROW AutoFuser Disposable Pain Control Pump
25060112312612ARROW AutoFuser Disposable Pain Control Pump
25060112312582ARROW AutoFuser Disposable Pain Control Pump
25060112312544ARROW AutoFuser Disposable Pain Control Pump
25060112312537ARROW AutoFuser Disposable Pain Control Pump
15060112312516AF 275x4ML/H 2ML-60LO FH 5" SAT C,4"IN
15060112312509AF 275 x 4ML/H 2ML-60LO FH STD C,4"IN
25060112312490ARROW AutoFuser Disposable Pain Control Pump
25060112312476ARROW AutoFuser Disposable Pain Control Pump
25060112312452ARROW AutoFuser Disposable Pain Control Pump
25060112312445ARROW AutoFuser Disposable Pain Control Pump
15060112312424AF 100x2ML/HR 2ML-60LO FH 5" SAT C,4" IN
15060112312417AF 100 x 2ML/H 2ML-60LO FH STD C,4"IN
15060112312363AF 275 x 2ML/H 2ML-60LO FH 5" SAT C,4"IN
15060112312356AF 275 x 2ML/H 2ML-60LO FH STD C,4"IN
25060112312322ARROW AutoFuser Disposable Pain Control Pump
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.