THERANOVA 955691

GUDID 37332414125715

Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure.

Gambro Dialysatoren GmbH

Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 37332414125715
• NIH Device Record Key: a479bc1b-e9fc-4ef1-88ac-a42c6a5f84b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERANOVA
• Version Model Number: 400
• Catalog Number: 955691
• Company DUNS: 316150549
• Company Name: Gambro Dialysatoren GmbH
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)229-0001
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Device Dimensions

• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter
• Area/Surface Area: 1.7 Square meter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414125714 [Primary]
GS1	37332414125715 [Package]; Contains: 07332414125714; Package: PACK_OR_INNER_PACK [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190042

FDA Product Code

• QAX: Hemodialyzer with expanded solute removal profile

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: 2020-09-10
• Device Publish Date: 2020-09-02

On-Brand Devices [THERANOVA]

• 37332414125715: Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range o
• 37332414125722: Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range o