AccessGUDID - DEVICE: EXPLANT RETURN KIT (00813024010241)

GUDID

Device Identifier (DI) Information

Brand Name: EXPLANT RETURN KIT
Version or Model: 28717
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28717
Company Name: Thoratec Corporation

Primary DI Number: 00813024010241
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use

Device Description: No description.

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?
14426	Contaminated waste container	A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials (e.g., waste products containing or having been in contact with human blood, sputum, urine and/or faeces). It is not intended to exclusively contain sharps or for in vitro diagnostic purposes. It is typically used with a disposable liner and has a self-closing lid. It is typically identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (Assisst) Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29bfba29-865b-4cea-98f7-b28003dd27a6
Public Version Date: August 18, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 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: 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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