α-spot

GUDID 00860802000390

LFP Alpha-Spot Kit

EASTERN BUSINESS FORMS INC

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• Primary Device ID: 00860802000390
• NIH Device Record Key: d8ff873c-715a-43f4-a14b-3326bfac911e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: α-spot
• Version Model Number: W201
• Company DUNS: 079861573
• Company Name: EASTERN BUSINESS FORMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860802000390 [Primary]
GS1	10860802000397 [Package]; Package: [7200 Units]; In Commercial Distribution

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

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: 2021-08-16
• Device Publish Date: 2021-08-06

On-Brand Devices [α-spot]

• 00860802000390: LFP Alpha-Spot Kit
• 10850039198035: LFP Alpha-Spot Kit