FDA.reportPublic FDA data

Eight Medical

Primary DI
00817278012587
Brand
Eight Medical
Company
Alliant Enterprises, LLC
Model
8510
Catalog number
8510
Device description
Myocardial temperature probe, 15mm needle, 8' length, 1/8" Plug
Published
2018-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0203650003TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLC2002-05-03KRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817278012587PackageGS125In Commercial Distribution
00817278012570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817278012587008172780125878172780125870817278012587
00817278012570008172780125708172780125700817278012570

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
121170653
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817278010132Surge Cardiovascular213-0251213-02512016-09-23
00817278010149Surge Cardiovascular213-026213-0262016-09-23
00817278010897Surge CardiovascularPER-1407S-C02PER-1407S-C022016-09-23
00817278010903Surge CardiovascularPER-1401S-C05PER-1401S-C052016-09-23
00817278011269Surge CardiovascularSSD-100ASSD-100A2016-09-23
00817278011696Surge Cardiovascular5756NS5756NS2018-03-27
00817278011979Surge Cardiovascular213-028213-0282016-09-23
00817278011986Surge Cardiovascular213-0252213-02522016-09-23
00817278012396Terumo Cardiovascular SystemsT402210T4022102018-04-25
00817278011276Surge CardiovascularSUC-4300SUC-43002016-09-23
00817278011757Surge CardiovascularSUC-0840SUC-08402016-09-23
10817278010009Surge CardiovascularSUT-010SUT-0102016-09-23
10817278010016Surge CardiovascularSUT-013SUT-0132016-09-23
10817278010023Surge Cardiovascular213-013213-0132016-09-23
10817278010887Surge CardiovascularSUT-014SUT-0142016-09-23
10817278011952MicroSurgeSUT-M110SUT-M1102016-09-23
10817278011969MicroSurgeSUT-M114SUT-M1142016-09-23
10817278010115Surge Cardiovascular213-002213-0022016-09-23
10817278010122Surge Cardiovascular213-004213-0042016-09-23
10817278010955Surge Cardiovascular213-003213-0032016-09-23

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