FDA.reportPublic FDA data

Test2 Release 1.6.3

Primary DI
14858218671008
Brand
Test2 Release 1.6.3
Company
Booz Allen Hamilton Inc.
Model
Test2XML
Catalog number
DRT
Device description
Test2 Release 1.6.3 XML Validation
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHXFLUOROMETRIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14858218671008PrimaryGS10
89786756453423Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1485821867100814858218671008
8978675645342389786756453423

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume200Centiliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-1.01 Degrees Fahrenheit1.01 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+00330476613501info@xxx.com

Regulatory Flags#

DUNS number
053588527
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14858218671006Test2 Release 1.6.3Test2XMLDRT2017-05-05
14858218671009Test2 Release 1.6.3Test2XMLDRT2017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590781521Access CK-MBBeckman Coulter, Inc.JHX2024-03-01
10758750034314VITROSORTHO CLINICAL DIAGNOSTICSJHX2022-10-24
00380740174941AlinityAbbott Ireland DiagnosticsJHX2019-11-11
00380740174927AlinityAbbott Ireland DiagnosticsJHX2019-06-07
30014613337157TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
00845275002348Thermo Scientific Fisher DiagnosticsJHX2017-06-22
14858218671006Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
14858218671009Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
00893038002807Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002719Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002795Alere Triage®Alere San Diego, Inc.JHX2016-09-26
14560189210728ST AIA-PACK CK-MBTOSOH CORPORATIONJHX2016-09-24
04560189211674AIA-PACK CK-MB Calibrator SetTOSOH CORPORATIONJHX2016-09-24
04560189211681AIA-PACK CK-MB Sample Diluting SolutionTOSOH CORPORATIONJHX2016-09-24
00842768004438Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004445Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004469Stratus® CS Acute Care™ CCRP TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004476Stratus CS Acute Care CCRP CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004490Stratus® CS Acute Care™ CKMB TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004506Stratus® CS Acute Care™ CKMB CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004513Stratus® CS Acute Care™ CKMB DilPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004520Stratus® CS Acute Care™ cTNI TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004537Stratus® CS Acute Care™ cTNI CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004544Stratus® CS Acute Care™ cTNI DilPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24