FDA.reportPublic FDA data

Parker Flex-Tip

Primary DI
10749065861443
Brand
Parker Flex-Tip
Company
SALTER LABS
Model
H-PSTDR-37
Catalog number
H-PSTDR-37
Device description
Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 37 Fr, O.D 11.5mm, I.D 4.4mm
Published
2017-08-30
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
30749065861447PackageGS11In Commercial Distribution
50749065861441PackageGS120In Commercial Distribution
10749065861443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3074906586144730749065861447
5074906586144150749065861441
1074906586144310749065861443

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 Diameter11.5Millimeter

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

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00607411102035Salter Labs8107V-02026-04-24
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10607411976237NebuTech8990TG-7-508990TG-7-502023-09-25
10607411001229Salter AIRE Elite8501-0-58501-0-52018-02-09
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