AccessGUDID - DEVICE: Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only (10607567107479)

GUDID

Device Identifier (DI) Information

Brand Name: Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only
Version or Model: 0684-00-0510-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0684-00-0510-02
Company Name: DATASCOPE CORP.

Primary DI Number: 10607567107479
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only

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?
44036	Intravascular catheter adaptor	A connecting device, usually a small part, intended to be used to join an applied catheter to an external device(s) used in the intravenous administration of fluids to a patient. This device will typically be used when the devices to be connected are from different manufacturers and are non-compatible, enabling them to mate together. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DSP	System, Balloon, Intra-Aortic And Control

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: 261d5252-1bb7-4e0d-9aae-bd0daef454e1
Public Version Date: December 09, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016