FDA Registration Active 🇲🇽 Mexico

86145 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4.5 mm)

Reg #: 9681384 · FEI: 3002807626 · Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Covidien
Registration Number
9681384
FEI Number
3002807626
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Avenue Henequen No. 1181, Park Industrial Salvarcar
City
Ciudad Juarez Chihuahua
Country
MX

Regulatory Submissions

510(k) Number
K223130

Owner / Operator

Firm Name
Covidien llc
Operator Number
1282497
Address
15 HAMPSHIRE STREET, --
City
Mansfield
State
MA
Postal Code
02048
Country
US

US Agent

Business Name
Covidien
Contact Name
Kae Miller
Address
6135 Gunbarrel Ave
City
Boulder
State
CO
ZIP
80301
Country
US
Phone
303 8768859

Products

Device Name Product Code
Tube, Tracheal (W/Wo Connector) BTR

Proprietary Names

86145 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4.5 mm) 86135 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (3.5 mm) 86150 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (5 mm) Shiley Pediatric Oral/Nasal ETT with TaperGuard Cuff 86130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (3 mm) 86140 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4 mm) 86155 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (5.5 mm) 86160 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (6 mm) 86125 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (2.5 mm)

Establishment Types

Manufacture Medical Device