AccessGUDID - DEVICE: Triton Canister System (00859506006135)

GUDID

Device Identifier (DI) Information

Brand Name: Triton Canister System
Version or Model: PN 11035
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STRYKER CORPORATION

Primary DI Number: 00859506006135
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61697	Blood loss estimation canister insert/label	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBZ	Image Processing Device For Estimation Of External Blood Loss

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142801	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3507efcd-f8fa-4d86-848d-ab9745d589ac
Public Version Date: June 05, 2024
Public Version Number: 2
DI Record Publish Date: June 25, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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