Parker H-PFOC-35

GUDID 10607411956017

Endotracheal Tube, Preformed, Oral, High Volume Low Pressure, Cuffed (PFOC), Parker, 3.5mm Parker Original DID: 10749065051356.

SALTER LABS

Basic endotracheal tube, single-use

• Primary Device ID: 10607411956017
• NIH Device Record Key: 666b9b4c-6f88-4426-a7a5-f6e87de9ad53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parker
• Version Model Number: H-PFOC-35
• Catalog Number: H-PFOC-35
• Company DUNS: 022721133
• Company Name: SALTER LABS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8004210024
• Email: customercare@salterlabs.com
• Phone: +8004210024
• Email: customercare@salterlabs.com
• Phone: +8004210024
• Email: customercare@salterlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411956010 [Primary]
GS1	10607411956017 [Package]; Contains: 00607411956010; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984528

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-20
• Device Publish Date: 2018-07-20

On-Brand Devices [Parker]

• 20607411959565: Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 39 Fr P
• 10607411959551: Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 37 Fr P
• 20607411959541: Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 35 Fr P
• 20607411959534: Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 32 Fr P
• 20607411959527: Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 28 Fr Park
• 20607411959510: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 41 Fr,
• 20607411959503: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 39 Fr,
• 20607411959497: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 37 Fr,
• 10607411959483: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 35 Fr,
• 20607411959473: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 32 Fr,
• 20607411959466: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 28 Fr,
• 20607411959459: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 6.0mm Parker Original DID
• 20607411959442: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 5.5mm Parker Original DID
• 20607411959435: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 5.0mm Parker Original DID
• 20607411959428: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 4.5mm Parker Original DID
• 20607411959411: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 4.0mm Parker Original DID
• 20607411959404: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 3.5mm Parker Original DID
• 20607411959398: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 3.0mm Parker Original DID
• 10607411959384: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 41 Fr, O.D
• 20607411959374: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 39 Fr, O.D
• 20607411959367: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 37 Fr, O.D
• 20607411659359: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 35 Fr, O.D
• 20607411659342: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 32 Fr, O.D
• 20607411959336: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 28 Fr, O.D
• 20607411959329: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 9.5mm Parker
• 20607411959312: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 9.0 mm Parke
• 20607411959305: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 8.5mm Parker
• 20607411959299: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 8.0 mm Parke
• 20607411959282: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 7.5mm Parker
• 20607411958018: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 7.0 mm Parke
• 20607411958001: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 6.5mm Parker
• 20607411957998: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 6.0 mm Parke
• 20607411957981: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 5.5mm Parker
• 20607411957974: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 5.0mm Parker
• 20607411957967: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 4.5mm Parker
• 20607411957950: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 4.0mm Parker
• 20607411957943: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 3.5mm Parker
• 10607411957939: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 3.0mm Parker
• 10607411957786: Parker Microlaryngeal Tube, High Volume Low Pressure Cuff (PMLT), 6.0mm Parker Original DID: 107
• 20607411957776: Parker Microlaryngeal Tube, High Volume Low Pressure Cuff (PMLT), 5.0mm Parker Original DID: 107
• 20607411957769: Parker Microlaryngeal Tube, High Volume Low Pressure Cuff (PMLT), 4.0mm Parker Original DID: 107
• 20607411957752: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 9
• 20607411957738: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 8
• 20607411957721: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 8
• 20607411957714: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 7
• 20607411957707: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 7
• 20607411957691: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 6
• 20607411657683: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCY), Parker, 6
• 20607411957677: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCL), Parker, 7
• 20607411957660: Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCL), Parker, 6