FDA.report

Parker Flex-Tip

Primary DI
50749065101806
Brand
Parker Flex-Tip
Company
SALTER LABS
Model
H-PFTVPU-80
Catalog number
H-PFTVPU-80
Device description
Parker Trach Vac with Flex-Tip and ThinCuff (H-PFTVPU), 8.0mm 
Published
2015-10-27
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

Related Records

Contact Domains

Product Codes

CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications

CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749065101802PackageGS110In Commercial Distribution
50749065101806PackageGS110In Commercial Distribution
10749065101808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3074906510180230749065101802
5074906510180650749065101806
1074906510180810749065101808

GMDN Terms

TermDefinition
Cuff-suction endotracheal tubeA hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter8Millimeter

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20889483224363MVAP Comfort Sleep Nasal CannulaHST332026-03-13
20889483225292MVAP Comfort Sleep Nasal CannulaSDC842026-03-13
20889483226435Bell Medical CannulaB180032C2026-03-13
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
10607411950503AirLife™2001-12001-12026-01-19
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 DIBrandCompanyProduct codePublished
24026704941043SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941057SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941064SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941074SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941081SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941095SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941101SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941118SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941128SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941132SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941149SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
44026704617195TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617201TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617211TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617235TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617911HUDSON RCITELEFLEX INCORPORATEDBTR2025-11-20
34026704930976SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930983SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930990SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931006SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931013SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931027SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931037SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931041SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931058SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30