Vapotherm

GUDID 10841737102509

Water Bottle Adapter and Disposable Patient Circuit High Flow

VAPOTHERM, INC.

High-flow heated respiratory humidifier

• Primary Device ID: 10841737102509
• NIH Device Record Key: b8c9e2fa-58d6-4de3-b437-2403161ae662
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vapotherm
• Version Model Number: PF-DPC-High-WBA
• Company DUNS: 040429050
• Company Name: VAPOTHERM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841737102502 [Primary]
GS1	10841737102509 [Package]; Contains: 00841737102502; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072845

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-03
• Device Publish Date: 2018-02-15

On-Brand Devices [Vapotherm]

• 00841737102915: Precision Flow Plus UKIT, Japan
• 00841737102908: Precision Flow HiVNI UKIT, Israel
• 00841737102892: Precision Flow Plus Vapotherm Transfer Unit, DISS
• 00841737102885: Precision Flow Vapotherm Transfer Unit, DISS Rental
• 00841737102878: Precision Flow HiVNI UKIT, Mexico
• 00841737102861: Precision Flow HiVNI UKIT, Chile
• 00841737102854: Precision Flow HiVNI UKIT, Colombia
• 00841737102847: Precision Flow HiVNI UKIT, Argentina
• 00841737102830: Precision Flow Heliox UKIT, Switzerland
• 00841737102823: Precision Flow Heliox UKIT, Italy
• 00841737102816: Precision Flow Heliox UKIT, Israel
• 00841737102809: Precision Flow Heliox UKIT, France
• 00841737102793: Precision Flow Heliox UKIT, Spain
• 00841737102786: Precision Flow Heliox UKIT, Canada
• 00841737102779: Precision Flow Heliox UKIT, Mexico
• 00841737102762: Precision Flow Heliox UKIT, Turkey
• 00841737102755: Precision Flow Heliox UKIT, Germany
• 00841737102748: Precision Flow Heliox UKIT, United Kingdom
• 00841737102731: Precision Flow Heliox UKIT, US
• 00841737102724: Precision Flow Classic UKIT, US
• 00841737102717: Precision Flow HiVNI UKIT, Slovakia
• 00841737102700: Precision Flow HiVNI UKIT, Sweden
• 00841737102694: Precision Flow HiVNI UKIT, Poland
• 00841737102687: Precision Flow HiVNI UKIT, Netherlands
• 00841737102670: Precision Flow HiVNI UKIT, Italy
• 00841737102663: Precision Flow HiVNI UKIT, France
• 00841737102656: Precision Flow HiVNI UKIT, Spain
• 00841737102649: Precision Flow HiVNI UKIT, Denmark
• 00841737102632: Precision Flow HiVNI UKIT, Czech
• 00841737102625: Precision Flow HiVNI UKIT, Switzerland
• 00841737102618: Precision Flow HiVNI UKIT, Canada
• 00841737102601: Precision Flow HiVNI UKIT, Belgium
• 00841737102595: Precision Flow HiVNI UKIT, Australia
• 00841737102588: Precision Flow HiVNI UKIT, Japan
• 00841737102571: Precision Flow HiVNI UKIT, Turkey
• 00841737102564: Precision Flow HiVNI UKIT, Germany
• 00841737102557: Precision Flow HiVNI UKIT, United Kingdom
• 00841737102540: Precision Flow HiVNI UKIT United States
• 00841737102533: Precision Flow Plus UKIT Belgium
• 10841737102523: VapoSoft Adult Nasal Cannula
• 10841737102516: VapoSoft Pediatric Small Nasal Cannula
• 10841737102509: Water Bottle Adapter and Disposable Patient Circuit High Flow
• 10841737102493: Water Bottle Adapter and Disposable Patient Circuit Low Flow
• 00841737102489: PF-VTU-BATTERY
• 00841737102472: PF-Plus-UKIT-SE
• 10841737102417: Brazil Disposable Patient Circuit Low Flow
• 10841737102394: Brazil Disposable Patient Circuit HighFlow
• 00841737102380: Pediatric/Adult Small Hi-VNI Nasal Cannula
• 00841737102366: Adult Single Prong Hi-VNI Nasal Cannula
• 10841737102349: Adult Hi-VNI Nasal Cannula