Forsure

Primary DI
00815123011846
Brand
Forsure
Company
FORSURE MEDICAL PRODUCTS LLC
Model
11200035
Catalog number
11200035
Device description
A 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.
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10815123011843PackageGS110In Commercial Distribution
20815123011840PackageGS1100In Commercial Distribution
00815123011846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081512301184310815123011843
2081512301184020815123011840
00815123011846008151230118468151230118460815123011846

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; it does not include an antimicrobial agent(s). 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 available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT STORE IN DIRECT SUNLIGHT
Special Storage Condition, Specify00KEEP AWAY FROM HIGH TEMPERATURE AND HIGH HUMIDITY

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
033809722
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897633001012Forsure90018150900181502017-10-05
00815123010030Forsure16300021163000212018-01-23
00897633001654Forsure16300024163000242018-01-23
00897633001661Forsure16300030163000302018-02-12
00897633001678Forsure16402000164020002018-02-12
00897633001685Forsure16402001164020012018-02-12
20897633001672Forsure16402000164020002018-02-12
20897633001689Forsure16402001164020012018-02-12
00815123010153Forsure11200065112000652018-02-07
00815123010207Forsure11210025112100252018-02-07
00815123010214Forsure11210030112100302018-02-07
00815123010221Forsure11210035112100352018-02-07
00815123011822Forsure 11200025112000252017-10-23
00815123011853Forsure11200040112000402017-10-24
00815123011860Forsure11200045112000452017-10-25
00815123011877Forsure11200050112000502017-10-25
00815123011884Forsure11200055112000552017-10-25
00815123011891Forsure11210040112100402017-10-25
00815123011907Forsure11210045112100452017-10-25
00815123011914Forsure11210050112100502017-10-25

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