FDA.reportPublic FDA data

Parker Flex-Tip

Primary DI
10749065061508
Brand
Parker Flex-Tip
Company
SALTER LABS
Model
H-PFTDL-41
Catalog number
H-PFTDL-41
Device description
Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 41 Fr, O.D 12.0mm, I.D 5.0mm
Published
2016-01-31
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

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749065061506PackageGS120In Commercial Distribution
10749065061508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5074906506150650749065061506
1074906506150810749065061508

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
Lumen/Inner Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
303-799-1990kmcgregor@parkermedical.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411890178N/A891289122016-09-24
00607411890185N/A891389132016-09-24
00607411890246N/A892389232016-09-24
00607411000881N/A5006-15006-12016-09-24
00607411917332Salter LabsOTC-101-7 (QTY 5)OTC-101-7 (QTY 5)2026-10-07
00607411917363Salter LabsOTC-102-4 (QTY 5)OTC-102-4 (QTY 5)2026-10-07
00607411917394Salter LabsOTC-102-7 (QTY 5)OTC-102-7 (QTY 5)2026-10-07
00607411000966AirLife7001-07001-02016-11-30
00607411001130AirLife1220-01220-02016-11-30
00607411001215AirLife1225-01225-02016-11-30
00607411888922N/AM5120-0M5120-02016-09-24
00607411917615n/aOTC-203-25 (QTY1)OTC-203-25 (QTY1)2016-11-30
00607411917646n/aOTC-203-50 (QTY1)OTC-203-50 (QTY1)2016-11-30
00607411918346Salter AIRE EliteSO-1774BESO-1774BE2016-09-24
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24

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