Adcuff™ 8450-3N-1L

GUDID 00634782300043

ADCUFF Neo SPU Cuff, 1 Tube,Size 3, Green, Luer, 10/pkg

AMERICAN DIAGNOSTIC CORP

Blood pressure cuff, reusable
Primary Device ID00634782300043
NIH Device Record Key122a95c6-92fb-4a6f-94ae-a502b71eefc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdcuff™
Version Model Number8450-3N-1L
Catalog Number8450-3N-1L
Company DUNS108999095
Company NameAMERICAN DIAGNOSTIC CORP
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100634782084523 [Primary]
GS100634782300043 [Package]
Contains: 00634782885922
Package: Master Case [5 Units]
In Commercial Distribution
GS100634782885922 [Package]
Contains: 00634782084523
Package: Inner Pack [10 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-22
Device Publish Date2018-02-10

On-Brand Devices [Adcuff™ ]

00634782586485ADCUFF SPU Inflation System,Thigh, Brown, 5/pkg
00634782586478ADCUFF SPU Inflation System,Large Adult Long, Burgundy, 5/pkg
00634782586461ADCUFF SPU Inflation System,Large Adult, Burgundy, 5/pkg
00634782586454ADCUFF SPU Inflation System,Adult Long, Navy, 5/pkg
00634782586447ADCUFF SPU Inflation System,Adult, Navy, 5/pkg
00634782586430ADCUFF SPU Inflation System,Small Adult, Royal Blue, 5/pkg
00634782586423ADCUFF SPU Inflation System,Child, Green, 5/pkg
00634782586416ADCUFF SPU Inflation System,Infant, Orange, 5/pkg
00634782586393ADCUFF SPU Cuff, 2 Tube,Thigh, Brown, No Conn, 20/pkg
00634782586386ADCUFF SPU Cuff, 2 Tube,Lrg Adult Long, Burgundy, No Conn, 20/pkg
00634782586379ADCUFF SPU Cuff, 2 Tube,Large Adult, Burgundy, No Conn, 20/pkg
00634782586362ADCUFF SPU Cuff, 2 Tube,Adult Long, Navy, No Conn, 20/pkg
00634782586355ADCUFF SPU Cuff, 2 Tube,Adult, Navy, No Conn, 20/pkg
00634782586331ADCUFF SPU Cuff, 2 Tube,Child, Green, No Conn, 20/pkg
00634782586324ADCUFF SPU Cuff, 2 Tube,Infant, Orange, No Conn, 20/pkg
00634782586317ADCUFF SPU Cuff, 1 Tube,Thigh, Brown, No Conn, 20/pkg
00634782586300ADCUFF SPU Cuff, 1 Tube,Lrg Adult Long, Burgundy, No Conn, 20/pkg
00634782586294ADCUFF SPU Cuff, 1 Tube,Large Adult, Burgundy, No Conn, 20/pkg
00634782586287ADCUFF SPU Cuff, 1 Tube,Adult Long, Navy, No Conn, 20/pkg
00634782586270ADCUFF SPU Cuff, 1 Tube,Adult, Navy, No Conn, 20/pkg
00634782586256ADCUFF SPU Cuff, 1 Tube,Child, Green, No Conn, 20/pkg
00634782586249ADCUFF SPU Cuff, 1 Tube,Infant, Orange, No Conn, 20/pkg
00634782585976ADCUFF Neo SPU Cuff, 2 Tube,Size 5, Burgundy, Luer, 10/pkg
00634782585877ADCUFF SPU Cuff, 2 Tube,Thigh, Brown, SC Conn, 20/pkg
00634782585860ADCUFF SPU Cuff, 1 Tube,Thigh, Brown, HP Conn, 20/pkg
00634782585853ADCUFF SPU Cuff, 2 Tube,Lrg Adult Long, Burgundy, SC Conn, 20/pkg
00634782585846ADCUFF SPU Cuff, 1 Tube,Lrg Adult Long, Burgundy, HP Conn, 20/pkg
00634782585839ADCUFF SPU Cuff, 2 Tube,Large Adult, Burgundy, SC Conn, 20/pkg
00634782585822ADCUFF SPU Cuff, 1 Tube,Large Adult, Burgundy, HP Conn, 20/pkg
00634782585815ADCUFF SPU Cuff, 2 Tube,Adult Long, Navy, SC Conn, 20/pkg
00634782585808ADCUFF SPU Cuff, 1 Tube,Adult Long, Navy, HP Conn, 20/pkg
00634782585792ADCUFF SPU Cuff, 2 Tube,Adult, Navy, SC Conn, 20/pkg
00634782585785ADCUFF SPU Cuff, 1 Tube,Adult, Navy, HP Conn, 20/pkg
00634782585778ADCUFF SPU Cuff, 2 Tube,Small Adult, Royal Blue, SC Conn, 20/pkg
00634782585761ADCUFF SPU Cuff, 1 Tube,Small Adult, Royal Blue, HP Conn, 20/pkg
00634782585754ADCUFF SPU Cuff, 2 Tube,Child, Green, SC Conn, 20/pkg
00634782585747ADCUFF SPU Cuff, 1 Tube,Child, Green, HP Conn, 20/pkg
00634782585730ADCUFF SPU Cuff, 2 Tube,Infant, Orange, SC Conn, 20/pkg
00634782585723ADCUFF SPU Cuff, 1 Tube,Infant, Orange, HP Conn, 20/pkg
00634782085315Bayonet Connector, Female,10/pkg
00634782085179Adapter/Connector-SPU, 2 Tube,2 Screw, F – Nothing
00634782085162Adapter/Connector-SPU, 2 Tube,2 Screw, F - Bayonet, M
00634782085155Adapter/Connector-SPU, 2 Tube,2 Screw, F–2 Marquette, F
00634782085148Adapter/Connector-SPU, Y Tube,2 Screw, F – Nothing
00634782085131Adapter/Connector-SPU, Y Tube,2 Screw, F – Bayonet, M
00634782085124Adapter/Connector-SPU, Y Tube,2 Screw, F - Marquette, F
00634782085117Adapter/Connector-SPU, 1 Tube,Bayonet, F – Nothing
00634782085100Adapter/Connector-SPU, 1 Tube,Bayonet, F – Screw, M
00634782085094Adapter/Connector-SPU, 1 Tube,Bayonet, F – Marquette, F
00634782586348ADCUFF SPU Cuff, 2 Tube,Small Adult, Royal Blue, No Conn, 20/pkg
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