Rapr Round 8001-061-630

GUDID 57613327261344

STRYKER CORPORATION

Circulating-fluid whole-body heating/cooling system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable
Primary Device ID57613327261344
NIH Device Record Key5b4773a8-53c7-4c35-ba28-6fb07e0a0689
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapr Round
Version Model Number8001-061-630
Catalog Number8001-061-630
Company DUNS078470558
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327261349 [Primary]
GS157613327261344 [Package]
Contains: 07613327261349
Package: case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, thermal regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-16

On-Brand Devices [Rapr Round]

576133272614058001-061-660
576133272613998001-061-650
576133272613828001-061-640
576133272613448001-061-630
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