Sealed CoolMini Applicator

GUDID 00816417021190

Applicator, Sealed CoolMini (NRR)

Zeltiq Aesthetics, Inc.

Cryolipolysis body contouring system applicator

• Primary Device ID: 00816417021190
• NIH Device Record Key: 1069f5ec-b567-4a5d-8cdf-1b32423b651f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sealed CoolMini Applicator
• Version Model Number: CS-300650
• Company DUNS: 809152916
• Company Name: Zeltiq Aesthetics, Inc.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816417021190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171069

FDA Product Code

• OOK: Dermal Cooling Pack/Vacuum/Massager

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: 2018-09-12
• Device Publish Date: 2018-08-12

Devices Manufactured by Zeltiq Aesthetics, Inc.

• 00816417022746 - Curve 135 (C135) Applicator: 2024-04-03 CoolSculpting System Applicator Curve 135 (C135)
• 00816417021008 - CoolCurve Applicator: 2021-08-20 CoolCurve Applicator
• 00816417021329 - CoolSculpting Applicator Cable Support Arm: 2021-08-16 Applicator Cable Support Arm
• 00816417021350 - CoolAdvantage Petite Comfort Strap: 2021-08-16 CoolAdvantage Petite Comfort Strap
• 00816417022739 - CoolMini Support Arm System: 2021-08-16 Support Arm System, CoolMini
• 00816417023064 - CoolMini Securement Straps: 2021-08-16 Assembly, Pouched Securement Straps, CoolMini
• 00816417022586 - CoolSculpting Umbilical Cable Assembly 2.3m: 2021-06-23 CoolSculpting Umbilical Cable Assembly 2.3m
• 00816417022593 - CoolSculpting Umbilical Cable Assembly 2.6m: 2021-06-23 CoolSculpting Umbilical Cable Assembly 2.6m