FDA.reportPublic FDA data

Triton Canister System

Primary DI
00859506006104
Brand
Triton Canister System
Company
STRYKER CORPORATION
Model
PN 11033
Device description
Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)
Published
2018-02-16
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
PBZImage Processing Device For Estimation Of External Blood Loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBZImage Processing Device For Estimation Of External Blood LossGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859506006104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859506006104008595060061048595060061040859506006104

GMDN Terms#

Term, Definition table
TermDefinition
Blood loss estimation canister insert/labelA device in the form of a shaped plastic insert or an adhesive sticker intended to be placed in and/or on a surgical suction system canister to facilitate estimation of the quantity of external blood loss during a surgical procedure. It provides a uniform background and standardization of ambient lighting conditions to improve the quality of images taken by a device that runs blood loss estimation application software. The label may also be used as a device identifier. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327622768TritonSTRYKER CORPORATIONPBZ2024-02-12
07613327622782N/ASTRYKER CORPORATIONPBZ2024-02-12
00859506006173TRITONSTRYKER CORPORATIONPBZ2022-12-23
00859506006258TRITONSTRYKER CORPORATIONPBZ2022-12-22
10859506006132Triton Canister SystemSTRYKER CORPORATIONPBZ2018-06-25
00859506006128TRITONSTRYKER CORPORATIONPBZ2018-06-25
00859506006135Triton Canister SystemSTRYKER CORPORATIONPBZ2018-06-25
10859506006101Triton Canister SystemSTRYKER CORPORATIONPBZ2018-02-16
10859506006095Triton Sponge- NUI Sensor bracketSTRYKER CORPORATIONPBZ2017-08-09
00859506006067TRITONSTRYKER CORPORATIONPBZ2017-08-09
00859506006081TRITONSTRYKER CORPORATIONPBZ2017-08-09
00859506006098Triton Sponge System- NUI Sensor BracketSTRYKER CORPORATIONPBZ2017-08-09
10859506006019Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
10859506006033Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
10859506006040Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006012Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006029TRITONSTRYKER CORPORATIONPBZ2016-10-05
00859506006036Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006043Triton Canister SystemSTRYKER CORPORATIONPBZ2016-10-05
00859506006050Triton System (Sponge)STRYKER CORPORATIONPBZ2016-10-05