AMPLION CLINICAL COMMUNICATIONS, INC.

Address:632 Melrose Ave,Nashville,TN,37211,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Environmental Control, Powered (IQA) (10)

Premarket Exempt

Yes

Clear

Amplion Care Assurance - 00850016398000 Catalog Number : D-BIS-13-1

Device Description : Bed Input Station (BIS), Version 1.3

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398017 Catalog Number : D-ADD-X-1

Device Description : Alert Display Driver (ADD) - Configuration 1

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398024 Catalog Number : D-ADD-X-2

Device Description : Alert Display Driver (ADD) - Configuration 2 (curved)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398031 Catalog Number : D-CDIS-12-1

Device Description : Clinical Device Input Station (CDIS), Version 1.2 - Configuration 1 includes a k Clinical Device Input Station (CDIS), Version 1.2 - Configuration 1 includes a keypad with the following features: Bed (red), Pulse Ox (blue), IV (purple)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398048 Catalog Number : D-CDIS-12-2

Device Description : Clinical Device Input Station (CDIS), Version 1.2 - Configuration 2 includes a k Clinical Device Input Station (CDIS), Version 1.2 - Configuration 2 includes a keypad with the following features: Vent (green), Pad (yellow), BiPap (brown)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398055 Catalog Number : D-CDIS-12-3

Device Description : Clinical Device Input Station (CDIS), Version 1.2 - Configuration 3 includes a k Clinical Device Input Station (CDIS), Version 1.2 - Configuration 3 includes a keypad with the following features: Bed (red), Pad (yellow), BiPap (brown)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398062 Catalog Number : D-CDIS-12-4

Device Description : Clinical Device Input Station (CDIS), Version 1.2 - Configuration 4 includes a k Clinical Device Input Station (CDIS), Version 1.2 - Configuration 4 includes a keypad with the following features: Bed (red), Pad (yellow), IV (purple)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398079 Catalog Number : D-CDIS-20-1

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 1 includes a k Clinical Device Input Station (CDIS), Version 2.0 - Configuration 1 includes a keypad with the following features: Bed (red), Pulse Ox (blue), IV (purple)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398086 Catalog Number : D-CDIS-20-2

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 2 includes a k Clinical Device Input Station (CDIS), Version 2.0 - Configuration 2 includes a keypad with the following features: Vent (green), Pad (yellow), BiPap (brown)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398093 Catalog Number : D-CDIS-20-3

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 3 includes a k Clinical Device Input Station (CDIS), Version 2.0 - Configuration 3 includes a keypad with the following features: Bed (red), Pad (yellow), BiPap (brown)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

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