FDA.reportPublic FDA data

CoolMini Card

Primary DI
00816417020148
Brand
CoolMini Card
Company
Zeltiq Aesthetics, Inc.
Model
BRZ-CD4-02X-001
Catalog number
BRZ-CD4-02X-001
Device description
CoolMini Card, 1 Cycle, CD4
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOKDermal Cooling Pack/Vacuum/Massager

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOKDermal Cooling Pack/Vacuum/MassagerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816417020148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816417020148008164170201488164170201480816417020148

GMDN Terms#

Term, Definition table
TermDefinition
Cryolipolysis body contouring system program cardA portable electronic device designed to connect to the data port of a cryolipolysis body contouring system to provide its control unit with a selected treatment profile. It contains data such as cooling intensity factor (CIF), cycle time and other relevant treatment data, and is factory programmed so that the data cannot be modified. It is made of metal and plastic materials and has a connector at one end to connect to computerized devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-935-8471support@zeltiq.com

Regulatory Flags#

DUNS number
809152916
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816417022555CoolSculpting EliteCS-SG-S18-01-002026-05-22
00816417022579CoolSculpting EliteCS-FB-185-01-002026-05-22
00816417023088CoolSculpting EliteCS-A3018S-002026-05-22
00816417023538CoolSculpting EliteCS-GL-XLG-10-002026-05-22
00816417021510Gel Trap C80CS-GT-08C-10-002020-08-31
00816417022487CoolSculpting EliteCS-CS-D01-01-002026-03-27
00816417023767CoolSculpting Elite299012412026-03-27
00816417022746Curve 135 (C135) ApplicatorCS-A3-13C-00CS-A3-13C-002024-03-26
10816417020152CoolSmooth Foam Borders BRZ-FB1-09X-024 BRZ-FB1-09X-0242016-09-23
10816417020541CoolSmooth Securement SystemBRZ-SS1-09X-012BRZ-SS1-09X-0122016-09-23
10816417020558CoolSmooth Securement SystemBRZ-SS2-09X-012BRZ-SS2-09X-0122016-09-23
10816417020565CoolSmooth PRO Securement StrapsBRZ-SS3-09X-012BRZ-SS3-09X-0122016-09-23
10816417020671CoolAdvantage GasketBRZ-LN2-160-024BRZ-LN2-160-0242016-09-23
10816417020916CoolAdvantage Petite Gasket - 24 PackBRZ-LN1-140-024BRZ-LN1-140-0242017-03-15
00816417021329CoolSculpting Applicator Cable Support ArmBRZ-RP1-ARM-001BRZ-RP1-ARM-0012021-08-06
00816417021350CoolAdvantage Petite Comfort StrapBRZ-SS1-140-002BRZ-SS1-140-0022021-08-06
00816417022739CoolMini Support Arm SystemBRZ-RP2-ARM-001BRZ-RP2-ARM-0012021-08-06
00816417023064CoolMini Securement StrapsBRZ-SS7-02X-002BRZ-SS7-02X-0022021-08-06
00816417021664CoolSculpting Securement System Straps-SmallCS-SS-SM-02-00CS-SS-SM-02-002021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150cs-ss-s15-02-00cs-ss-s15-02-002021-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816417022555CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417022579CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417023088CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417023538CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-05-22
00816417022487CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-03-27
00816417023767CoolSculpting EliteZeltiq Aesthetics, Inc.OOK2026-03-27
00816417022746Curve 135 (C135) ApplicatorZeltiq Aesthetics, Inc.OOK2024-03-26
00816417021008CoolCurve ApplicatorZeltiq Aesthetics, Inc.OOK2021-08-12
00816417021329CoolSculpting Applicator Cable Support ArmZeltiq Aesthetics, Inc.OOK2021-08-06
00816417021350CoolAdvantage Petite Comfort StrapZeltiq Aesthetics, Inc.OOK2021-08-06
00816417022739CoolMini Support Arm SystemZeltiq Aesthetics, Inc.OOK2021-08-06
00816417023064CoolMini Securement StrapsZeltiq Aesthetics, Inc.OOK2021-08-06
00816417022586CoolSculpting Umbilical Cable Assembly 2.3mZeltiq Aesthetics, Inc.OOK2021-06-15
00816417022593CoolSculpting Umbilical Cable Assembly 2.6mZeltiq Aesthetics, Inc.OOK2021-06-15
00816417021664CoolSculpting Securement System Straps-SmallZeltiq Aesthetics, Inc.OOK2021-04-30
00816417022609CoolSculpting Elite Card, Direct, US/CA, Solo,50TxZeltiq Aesthetics, Inc.OOK2021-04-30
00816417022630CoolSculpting Elite Securement Grip, S150Zeltiq Aesthetics, Inc.OOK2021-04-30
00816417022333CoolSculpting Elite Card, Direct, USA, CAN 10 Dual TXZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022449CoolSculpting Elite Card, NFS, Direct, USA, CAN Solo 4 TxZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022456CoolSculpting Elite Card, NFS, Direct, USA,CAN, Dual 4 TxZeltiq Aesthetics, Inc.OOK2021-01-31
00816417022463CoolSculpting Elite Card, Direct, USA, CAN 50 Dual TXZeltiq Aesthetics, Inc.OOK2021-01-31
00816417021343CoolSculpting Elite Quick-Check Card, 99 cycleZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021381CoolSculpting Elite Card, Direct, USA,CAN 20 Solo TrxZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021527CoolSculpting Quad Comfort StrapZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021749CoolSculpting Elite Card, Direct, USA, CAN, 25 Dual TXZeltiq Aesthetics, Inc.OOK2020-12-09
00816417021756CoolSculpting Elite Card, Direct, USA, CAN 100 Solo TXZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022302Foam Borders, S150 ApplicatorZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022319S150 LinerZeltiq Aesthetics, Inc.OOK2020-12-09
00816417022470CoolSculpting Elite Card, Solo,NSF, ZA20-002Zeltiq Aesthetics, Inc.OOK2020-12-09
00816417021718CoolSculpting System Applicator Surface 150 (S150)Zeltiq Aesthetics, Inc.OOK2020-10-31