FDA.reportPublic FDA data

Parker Flex-Tip

Primary DI
50749065021708
Brand
Parker Flex-Tip
Company
SALTER LABS
Model
H-PFUO-70
Catalog number
H-PFUO-70
Device description
Endotracheal Tube, Uncuffed (PFUO), Parker, 7.0mm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749065021704PackageGS110In Commercial Distribution
50749065021708PackageGS110In Commercial Distribution
10749065021700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3074906502170430749065021704
5074906502170850749065021708
1074906502170010749065021700

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter7Millimeter

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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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
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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
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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
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34026704941132SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941149SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
44026704617195TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
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34026704930990SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
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24026704931013SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931027SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931037SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931041SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931058SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
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05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30