DATEX-OHMEDA OMA-8652

GUDID B929OMA86520

1009-3036-000/ M91-4 PVT LABEL

WESTERN/SCOTT FETZER COMPANY

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• Primary Device ID: B929OMA86520
• NIH Device Record Key: 7949c862-da9f-402b-8c29-9cd38fc9ff7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DATEX-OHMEDA
• Version Model Number: OMA-8652
• Catalog Number: OMA-8652
• Company DUNS: 148634731
• Company Name: WESTERN/SCOTT FETZER COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	B929OMA86520 [Primary]
HIBCC	B929OMA86521 [Package]; Package: BOX [50 Units]; In Commercial Distribution

FDA Product Code

• CAM: Yoke Assembly, Medical Gas

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-08
• Device Publish Date: 2022-08-31

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• B929N4AI180OHFOXM0 - Western/Scott Fetzer: 2024-02-27 PKGD: N4-AIR-180-OHF-OXM
• B929N4OX180OHFOXM0 - Western/Scott Fetzer: 2024-02-27 PKGD: N4-OXY-180-OHF-OXM
• B929N4OX192FNNFNN0 - Western/Scott Fetzer: 2024-02-02 PKGD: N4-OXY-192-FNN-FNN
• B929C4OX048FNNMP20 - Western/Scott Fetzer: 2023-12-22 PKGD: C4-OXY-048-FNN-MP2