FDA.reportPublic FDA data

Amico Patient Care Corporation

Primary DI
07540200000323
Brand
Amico Patient Care Corporation
Company
Amico Patient Care Corporation
Model
SSD-NI
Device description
SENTINEL VACUUM REGULATOR, DIGITAL, NEO INTERMITTENT, 0 - 100MMHG
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540200000323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540200000323075402000003237540200000323

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, vacuumAn assembly of devices designed to evacuate fluid, tissue, gas, or foreign materials from a body cavity or lumen by means of suction. It is connected via dedicated vacuum tubing to the vacuum terminal unit (wall outlet) of a vacuum pipeline system and powered via a hospital's central vacuum system. It generally includes a regulator, tubing, an overflow trap, plastic/glass collection container(s), a suction tip, and possibly moisture/microbial filters. The regulator controls the vacuum in the suction tubing for the removal of materials into the collection container. This system can be used in a wide variety of hospital settings, but is limited to connection to a central vacuum system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
259676661
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540200000385Amico Patient Care CorporationFMA-152023-11-14
07540200000392Amico Patient Care CorporationFMO-152023-11-14
07540200000408Amico Patient Care CorporationFMO-012023-11-14
07540200000415Amico Patient Care CorporationFMO-022023-11-14
07540200000422Amico Patient Care CorporationFMO-032023-11-14
07540200000439Amico Patient Care CorporationFMO-082023-11-14
07540200000446Amico Patient Care CorporationFMA-702023-11-14
07540200000453Amico Patient Care CorporationFMO-702023-11-14
07540200000460Amico Patient Care CorporationFMA-25-D2023-11-14
07540200000477Amico Patient Care CorporationFMO-25-D2023-11-14
07540200000484Amico Patient Care CorporationFMO-04-D2023-11-14
07540200000491Amico Patient Care CorporationFMO-08-D2023-11-14
07540200000545Amico Patient Care CorporationFMO-15-D2023-11-14
07540200000552Amico Patient Care CorporationFMA-15-D2023-11-14
07540200000330Amico Patient Care CorporationAVA SERIES2016-09-24
07540200000347Amico Patient Care CorporationMARCO SERIES2016-09-24
07540200000354Amico Patient Care CorporationCONNOR SERIES2016-09-24
07540200000361Amico Patient Care CorporationJORDAN SERIES2017-09-12
07540200000378Amico Patient Care CorporationLILY SERIES2017-09-12
07540200000019Amico Patient Care CorporationSRA-C22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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