Neonate Cuff

GUDID 00847946026813

ASSY, CUFF, NEONATE #4, LIMB CIRCUMFERENCE 7.0 CM TO 13.0 CM, DISPOSABLE (BOX OF 20)

Zoll Medical Corporation

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Primary Device ID00847946026813
NIH Device Record Key1e120fb9-9799-43b2-8d46-d52d787e7843
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeonate Cuff
Version Model Number1009-001643
Company DUNS055363428
Company NameZoll Medical Corporation
Device Count1
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946026813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQblood pressure cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-17
Device Publish Date2023-11-09

On-Brand Devices [Neonate Cuff]

00847946026820ASSY, CUFF, NEONATE #5, LIMB CIRCUMFERENCE 8.0 CM TO 15.0 CM, DISPOSABLE (BOX OF 20)
00847946026813ASSY, CUFF, NEONATE #4, LIMB CIRCUMFERENCE 7.0 CM TO 13.0 CM, DISPOSABLE (BOX OF 20)
00847946026806NEONATAL DISPOSABLE CUFFS SIZE 3 [6.0-11.0 CM] (20 PER BOX)
00847946026790NEONATAL DISPOSABLE CUFFS SIZE 2 [4.0-8.0 CM] (20 PER BOX)
00847946026783CUFF, NEONATE #1, LIMB CIRCUMFERENCE 3.0 CM TO 6.0 CM, DISPOSABLE (BOX OF 20)

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