NIBP Cuffs M1571A

GUDID 00884838114654

Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions; limb circumference 10.0-15cm. Polyurethane bladder, hose, cover. No latex or PVC.

Philips Medizin Systeme Böblingen GmbH

Blood pressure cuff, reusable
Primary Device ID00884838114654
NIH Device Record Key9e0ffce2-81a4-48dd-93cf-9afcc71f1b04
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIBP Cuffs
Version Model NumberCOMFORT CARE CUFF, INFANT
Catalog NumberM1571A
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
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

Device Dimensions

Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0
Circumference15 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838114654 [Primary]

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-23

On-Brand Devices [NIBP Cuffs]

00884838009042Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838008588Infant Soft Single-Patient Cuff Size #5
00884838008564Neonatal Soft Single-Patient Cuff Size#4
00884838008540Neonatal Soft Single-Patient Cuff Size#3
00884838008526Neonatal Soft Single-Patient Cuff Size#2
00884838008502Neonatal Soft Single-Patient Cuff Size#1
00884838009127Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838009103Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838009080Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838009066Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114920Neonatal Soft Single-Patient NIBP Cuffs
00884838114791Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114784Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114777Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114760Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114753Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114746Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114739Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114722Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit
00884838114715Long-life reusable NIBP cuff/thigh. Premium quality individual cuff w/fluid cap and instructions
00884838114692Comfort Care Cuff, Adult Long (navy blue w/edge striping). Limb circumference 27-35cm. Reusable
00884838114678Long-life reusable NIBP cuff/small adult Premium quality individual cuff w/fluid cap and instruc
00884838114661Long-life reusable NIBP cuff/pediatric. Premium quality individual cuff w/fluid cap and instruct
00884838114654Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions;
00884838114708Long-life reusable NIBP cuff/large adult Premium quality individual cuff w/fluid cap and instruc
00884838114685Long-life reusable NIBP cuff/adult. Premium quality individual cuff w/fluid cap and instructions

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