AccessGUDID - DEVICE: JETSTREAM SC (00616258005133)

GUDID

Device Identifier (DI) Information

Brand Name: JETSTREAM SC
Version or Model: 112262-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112262
Company Name: Bayer Healthcare LLC

Primary DI Number: 00616258005133
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079415061 *Terms of Use

Device Description: JETSTREAM SC 1.85MM, FG PKG

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?
58171	Atherectomy/thrombectomy rotational catheter	A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of atheroma and clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing acute to chronic vascular obstruction in native and stented blood vessels, native and synthetic bypass, or haemodialysis access grafts, through a mechanical rotational action intended to shatter/erode the obstruction and aspirate debris for collection. It typically consists of a catheter with a rotating head with a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile covers and collecting bags may be included. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MCW	Catheter, Peripheral, Atherectomy

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: 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
Catheter Gauge: 7 French

Device Record Status

Public Device Record Key: ae3fa261-4d7e-4f9d-a44e-02e7eb97d34e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 09, 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 763-780-4555
Email: michael.burnside@bayer.com

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