Transonic

GUDID 00877466002011

TRANSONIC SYSTEMS INC.

Invasive vascular ultrasound system

• Primary Device ID: 00877466002011
• NIH Device Record Key: e55f529c-b353-4212-ab57-901aea94ac31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transonic
• Version Model Number: HQN8FME
• Company DUNS: 101317451
• Company Name: TRANSONIC SYSTEMS INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877466002011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872048

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

Sterilization

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

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00877466002011]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-16
• Device Publish Date: 2020-10-08

On-Brand Devices [Transonic]

• 00877466001531: HQC2FMC
• 08774660001531: HQC2FMC
• 00877466000130: HT364
• 00877466002080: HQC8FMV
• 00877466000895: HQD7XL
• 00877466000543: ABLPHR
• 00877466000536: ABLPHI
• 00877466000529: ABLPHE
• 00877466000512: ABLPHDI
• 00877466000505: BLF22A
• 00877466000499: BLF22
• 00877466000482: BLF21
• 00877466005791: ADT1010-40
• 00877466000451: H4FX
• 00877466000437: HD03
• 00877466000413: HFW1000
• 00877466000406: H9FX
• 00877466000390: H7FX
• 00877466000383: H6FX
• 00877466000376: HCE101
• 00877466000369: HCS3002-5
• 00877466000352: HCS3021-5
• 00877466000345: HCS3012-5
• 00877466000338: HCS3011-5
• 00877466000321: HCP01
• 00877466000307: HC2T
• 00877466000277: HCM101
• 00877466005777: ADT1002-10
• 00877466005760: ADT1001-10
• 00877466000239: HVT101
• 00877466000222: HVT100
• 00877466000123: HT363
• 00877466000116: HT360
• 00877466000062: HT353
• 00877466000055: HT353
• 00877466000048: HT350
• 00877466006897: HT353C
• 00877466005951: HT354C
• 00877466005708: HQE6AU
• 00877466005692: HQE4AU
• 00877466005647: AOS1005
• 00877466005630: HQD12XL-M20
• 00877466005623: HQD10XL-M16
• 00877466005616: HQD9XL-M14
• 00877466005609: HQD8XL-M12
• 00877466005593: HQD7XL-M10
• 00877466005586: HQD6XL-M9
• 00877466005579: HQD5XL-M8
• 00877466005562: HQD4XL-M7
• 00877466005555: HQD4XL-M6