AccessGUDID - DEVICE: Zephyr Vascular Compression Device (10815614020392)

GUDID

Device Identifier (DI) Information

Brand Name: Zephyr Vascular Compression Device
Version or Model: 9100-20
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 190-0100-20
Company Name: Semler Technologies, Inc.

Primary DI Number: 10815614020392
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 042075700 *Terms of Use

Device Description: The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-20 provides the large strap which 11.8”/30cm long.

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":	Yes
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?
58704	Radial artery compression device	A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151363	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: 1b06d4d4-abde-41db-8cfd-65df1fa9bc1c
Public Version Date: October 16, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016