AccessGUDID - DEVICE: ARROW (10801902208535)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN924153
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA-09847
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10801902208535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Sheath Adapter with Cath-Gard(R) Catheter Contamination Shield for use with 4 - 7 Fr. Catheters

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):	Yes
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?
31683	Electrocardiographic lead switching adaptor	A switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, catheter

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
No Device Sizes

Device Record Status

Public Device Record Key: 4ea01cb7-aacd-4da5-b0d0-6caf7b1678c7
Public Version Date: June 14, 2023
Public Version Number: 1
DI Record Publish Date: June 06, 2023