FDA.reportPublic FDA data

Parker Flex-Tip

Primary DI
50749065861403
Brand
Parker Flex-Tip
Company
SALTER LABS
Model
H-PSTDR-35
Catalog number
H-PSTDR-35
Device description
Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 35 Fr, O.D 10.5mm, I.D 4.0mm
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

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
30749065861409PackageGS11In Commercial Distribution
50749065861403PackageGS120In Commercial Distribution
10749065861405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3074906586140930749065861409
5074906586140350749065861403
1074906586140510749065861405

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 Diameter10.5Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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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30889483236325Iradimed Adult Capnography Cannula1842A2025-08-04
30889483236332Iradimed Infant Capnography Cannula1842I2025-08-04
30889483236349Iradimed Pediatric Capnography Cannula1842P2025-08-04
30889483236356Iradimed1843A2025-08-04
30889483236363Iradimed1843P2025-08-04
30889483236370Iradimed1844A2025-08-04
30889483236387Iradimed1844P2025-08-04
30889483236318Iradimed Sample Line Extension18412025-08-04
30889483610569Resmed Sleep Apnealink Cannula707103162025-07-11
20889483569990O2 Cannula001321U2024-12-31
20889483570019O2 Cannula001322U2024-12-31
20889483570040O2 Cannula001326U2024-12-31
20889483570156O2 Cannula0013652024-12-31
20889483571375O2 Cannula002600-25U2024-12-31
20889483571504O2 Cannula0026922024-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34026704941156SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
24026704941166SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
24026704941173SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
34026704941187SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
34026704941194SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
24026704941203SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
34026704941217SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
34026704941224HUDSON RCITELEFLEX INCORPORATEDCBI2025-12-11
24026704941234SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
24026704941241SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
08800115141801Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141818Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141825Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141832Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141849Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141856Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141863Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141870Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141924ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141931ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141948ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141955ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141962ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141979ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141986ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141993ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
34026704743347RUSCHTELEFLEX INCORPORATEDCBI2024-05-20
00811907031925Chartis Precision CatheterPULMONX CORPORATIONCBI2024-03-15
14544050123812UNIVENT TUBE (TCB TYPE)FUJI SYSTEMS CORPORATIONCBI2024-01-31
14544050123836UNIVENT TUBE (TCB TYPE)FUJI SYSTEMS CORPORATIONCBI2024-01-31