AtriCure cryoICE cryoSPHERE Cryoablation System A001009

GUDID 30840143902912

CRYOS, Packaged Assembly

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical

Primary Device ID	30840143902912
NIH Device Record Key	dff47955-ce98-4fbb-bdba-6761c6e3e1c2
Commercial Distribution Status	In Commercial Distribution
Brand Name	AtriCure cryoICE cryoSPHERE Cryoablation System
Version Model Number	CRYOS
Catalog Number	A001009
Company DUNS	006133784
Company Name	ATRICURE, 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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter
Length	8 Millimeter

Operating and Storage Conditions

Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -28 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354016321 [Previous]
GS1	10840143902543 [Primary]
GS1	30840143902912 [Package] Contains: 10840143902543 Package: box [1 Units] In Commercial Distribution
GS1	50840143902817 [Package] Package: box [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182565

FDA Product Code

GXH	Device, Surgical, Cryogenic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-01-18
Device Publish Date	2021-01-08

On-Brand Devices [AtriCure cryoICE cryoSPHERE Cryoablation System]

00818354016338	CRYOS-L, Packaged Assembly
00818354016321	CRYOS, Packaged Assembly
30840143902929	CRYOS-L, Packaged Assembly
30840143902912	CRYOS, Packaged Assembly