US IVD 48 Spot Target 8604532

GUDID 10841594110020

Reuseable Stainless Steel Target.

BRUKER DALTONICS INC.

Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD

• Primary Device ID: 10841594110020
• NIH Device Record Key: 1d604784-9a1b-4bd9-bfd4-3809f4dd874e
• Commercial Distribution Discontinuation: 2019-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: US IVD 48 Spot Target
• Version Model Number: 8604532
• Catalog Number: 8604532
• Company DUNS: 877298661
• Company Name: BRUKER DALTONICS INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841594110054 [Primary]
GS1	10841594110020 [Package]; Contains: 00841594110054; Package: Pack [5 Units]; Discontinued: 2019-05-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130831

FDA Product Code

• PEX: System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Sterilization

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

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

[10841594110020]

Peracetic Acid

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-25
• Device Publish Date: 2016-09-16

Devices Manufactured by BRUKER DALTONICS INC.

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• 00841594100031 - MALDI Biotyper - smart CA: 2020-02-25 Biotyper system for clinical use in the USA, with smart laser.
• 00841594110030 - MBT-CA System BD: 2020-02-25 Biotyper system for clinical use in the USA, for Becton Dickinson.
• 00841594110047 - BD Bruker MBT smart CA System: 2020-02-25 Biotyper system for clinical use in the USA with smart laser, for Becton Dickson.
• 10841594110020 - US IVD 48 Spot Target: 2020-02-25Reuseable Stainless Steel Target.
• 10841594110020 - US IVD 48 Spot Target: 2020-02-25 Reuseable Stainless Steel Target.
• 10841594110013 - US IVD-HCCA Matrix, Portioned 10 Tubes: 2020-02-25 HCCA Matrix, 10 tubes
• 10841594110099 - US IVD-Bruker Bacterial Test Standard, 5 Tubes: 2020-02-25 Bacterial Test Standard, 5 tubes.