FDA.reportPublic FDA data

Sunmed

Primary DI
20889483040765
Brand
Sunmed
Company
SUNMED, LLC
Model
1-7343-85
Device description
E/T TUBE CUFFED W/STYLET 8.5mm 34FR
Published
2016-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042683000WELL LEAD ENDOTRACHEAL TUBEWell Lead Medical Instruments2005-02-18BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483040765PackageGS110In Commercial Distribution
10889483040768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948304076520889483040765
1088948304076810889483040768

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length330Millimeter
Lumen/Inner Diameter8.5Millimeter
Outer Diameter11.33Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius
Special Storage Condition, Specify00Do not get wet. Keep out of direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483231494Ambu900-000-614900-000-6142025-12-19
10889483231524Ambu900-000-617900-000-6172025-12-19
10889483231531Ambu900-000-618900-000-6182025-12-19
10889483231586Ambu900-000-624900-000-6242025-12-19
10889483231616Ambu900-000-628900-000-6282025-12-19
10889483565339BALLARD™97012970122025-12-01
10889483565346BALLARD™97014970142025-12-01
10889483565360BALLARD™97020970202025-12-01
10889483565377BALLARD™97021970212025-12-01
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750709KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750716KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750723KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750730KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750747KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750754KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750761KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750778KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750785KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750792KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750808KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750815KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750495KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750518KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750525KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750587KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750594KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750600KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750617KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750624KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750631KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750648KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750655KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750662KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01