AccessGUDID - DEVICE: CO-SET+ (07460691950009)

GUDID

Device Identifier (DI) Information

Brand Name: CO-SET+
Version or Model: 93610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 93610
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691950009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: CO-SET DELIVERY SYSTEM FOR 123 ROOM TEMPATURE INJECTATE

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:	Yes
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?
10615	Thermal-dilution cardiac output unit	A unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRB	PROBE, THERMODILUTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K811399	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 66b07125-bd80-416a-aab2-525348fc5944
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 03, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
57460691950004	10	07460691950009		In Commercial Distribution	Shipper

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: No
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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