FDA.report

Parker Flex-Tip

Primary DI
50749065861502
Brand
Parker Flex-Tip
Company
SALTER LABS
Model
H-PSTDR-41
Catalog number
H-PSTDR-41
Device description
Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 41 Fr, O.D 12.0mm, I.D 5.0mm
Published
2017-08-30
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

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749065861508PackageGS11In Commercial Distribution
50749065861502PackageGS120In Commercial Distribution
10749065861504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3074906586150830749065861508
5074906586150250749065861502
1074906586150410749065861504

GMDN Terms

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

TypeValueUnit
Lumen/Inner Diameter12Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
303-799-1990kmcgregor@parkermedical.com

Regulatory Flags

DUNS number
022721133
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

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