Forsure

Primary DI
20815123012021
Brand
Forsure
Company
FORSURE MEDICAL PRODUCTS LLC
Model
11220028
Catalog number
11220028
Device description
A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.
Published
2017-10-27
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

Product Codes#

Code, Name table
CodeName
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092886000WELL LEAD ENDOBRONCHIAL TUBESWell Lead Instruments2010-03-11CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815123012024PackageGS11In Commercial Distribution
20815123012021PackageGS120In Commercial Distribution
00815123012027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081512301202410815123012024
2081512301202120815123012021
00815123012027008151230120278151230120270815123012027

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial tubeA hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
033809722
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
true
Contains natural rubber latex
false
No natural rubber latex
false
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
00815123011846Forsure11200035112000352017-10-24
00815123011853Forsure11200040112000402017-10-24
00815123011860Forsure11200045112000452017-10-25
00815123011877Forsure11200050112000502017-10-25
00815123011884Forsure11200055112000552017-10-25
00815123011891Forsure11210040112100402017-10-25
00815123011907Forsure11210045112100452017-10-25

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