ADVANCED NEONATAL INCUBATOR

GUDID B510A31860

ADVANCED INSTRUMENTATIONS, INC.

Conventional infant incubator

• Primary Device ID: B510A31860
• NIH Device Record Key: 30ddbdc0-2112-4c55-bb6b-4ef87fac2077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED NEONATAL INCUBATOR
• Version Model Number: A3186
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, 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: 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
HIBCC	B510A31860 [Primary]

FDA Product Code

• FMZ: Incubator, Neonatal

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: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [ADVANCED NEONATAL INCUBATOR]

• B510A31861: A3186+
• B510A31860: A3186