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 - 00850016398109 Catalog Number : D-CDIS-20-4

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 4 includes a k Clinical Device Input Station (CDIS), Version 2.0 - 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 - 00850016398116 Catalog Number : D-CDIS-20-5

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 5 includes a k Clinical Device Input Station (CDIS), Version 2.0 - Configuration 5 includes a keypad with the following features: Pulse Ox (blue), Pad (yellow), Vent (green)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398123 Catalog Number : D-CDIS-20-6

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 6 includes a k Clinical Device Input Station (CDIS), Version 2.0 - Configuration 6 includes a keypad with the following features: Pulse Ox (blue), 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 - 00850016398130 Catalog Number : D-CDIS-20-7

Device Description : Clinical Device Input Station (CDIS), Version 2.0 - Configuration 7 includes a k Clinical Device Input Station (CDIS), Version 2.0 - Configuration 7 includes a keypad with the following features: BiPap (brown), Pad (yellow), Pulse Ox (blue)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398147 Catalog Number : D-CAS-11-1

Device Description : Care Assurance Station (CAS), Version 1.1

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398154 Catalog Number : D-CPS-10-1

Device Description : Code Pink Station (CPS), Version 1.0

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398161 Catalog Number : D-DB-10-1

Device Description : Daughter Board (DB), Version 1.0 - Configuration 1 includes a keypad with the fo Daughter Board (DB), Version 1.0 - Configuration 1 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 - 00850016398178 Catalog Number : D-DS-11-1

Device Description : Duty Station (DS), Version 1.1

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398185 Catalog Number : D-ES-10-1

Device Description : Emergency Station (ES), Version 1.0

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398192 Catalog Number : D-MNC-X-1

Device Description : Mushroom Nurse Call Button (MNC) with cable harness

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

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