AccessGUDID - DEVICE: Affinity™ CP (00763000301323)

GUDID

Device Identifier (DI) Information

Brand Name: Affinity™ CP
Version or Model: AP40AST
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000301323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: ADAPTER AP40AST AFFINITY CP WW 31L

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:	No
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?
31718	Cardiopulmonary bypass system centrifugal pump	A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFM	Pump, blood, cardiopulmonary bypass, non-roller type

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132712	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
Special Storage Condition, Specify: Avoid storing the adapter in direct sunlight
Storage Environment Temperature: between -30 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106.3 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106.3 KiloPascal
Special Storage Condition, Specify: Keep dry
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Do not store at extremes of temperature and humidity
Special Storage Condition, Specify: This way up

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 94.0 Millimeter
Height: 28.0 Millimeter
Weight: 315.0 Gram

Device Record Status

Public Device Record Key: 18ce8ff8-1ad8-4f96-b34a-adeca3cb00c5
Public Version Date: June 08, 2020
Public Version Number: 1
DI Record Publish Date: May 31, 2020

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

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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