HNI 4500 6489

GUDID 04054657500501

UV - Tanning lamp

G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH

Ultraviolet tanning device

• Primary Device ID: 04054657500501
• NIH Device Record Key: bbac2e36-112a-48f8-9dfb-e852a3574699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HNI
• Version Model Number: Strahler HNI 468 S (BQ 468 z4)
• Catalog Number: 4500 6489
• Company DUNS: 312827900
• Company Name: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
• 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: false
• Lot Batch: true
• Serial Number: true
• 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: true

Customer Support Contacts

• Phone: +4961814902316
• Email: info@original-hanau.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04054657500501 [Primary]
GS1	14054657500508 [Package]; Package: SecondaryPackaging [1 Units]; In Commercial Distribution
GS1	54054657600503 [Package]; Contains: 14054657500508; Package: CaseTertiary 100x [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151674

FDA Product Code

• LEJ: Booth, Sun Tan

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-18
• Device Publish Date: 2017-02-28

On-Brand Devices [HNI]

• 04054657500501: UV - Tanning lamp
• 04054657500495: UV - Tanning lamp, Accession # 8821935-17 Exclusive distributor for USA: HN Sunlight GmbH,
• 04054657500488: UV - Tanning lamp, Accession # 8821935-04 Exclusive distributor for USA: HN Sunlight GmbH,
• 04054657500075: UV - Tanning lamp, Accession # 0631196-001 Exclusive distributor for USA: HN Sunlight GmbH,
• 04054657500068: UV - Tanning lamp, Accession # 0631196-001 Exclusive distributor for USA: HN Sunlight GmbH,