AccessGUDID - DEVICE: Impella (00813502011135)

GUDID

Device Identifier (DI) Information

Brand Name: Impella
Version or Model: 0043-0003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0043-0003
Company Name: Abiomed, Inc.

Primary DI Number: 00813502011135
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 050636737 *Terms of Use

Device Description: Purge Cassette, 5 Pack

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?
57791	Infusion pump cassette	A sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140003	000
P170011	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddd5664c-0e26-4bc4-aef8-60c28110d9db
Public Version Date: June 20, 2023
Public Version Number: 5
DI Record Publish Date: July 31, 2014

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: 00813502010510 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: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 978.777.5410
Email: wbolt@abiomed.com

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