AccessGUDID - DEVICE: CompressAR Elliptical Comfort Disc (10815614020200)

GUDID

Device Identifier (DI) Information

Brand Name: CompressAR Elliptical Comfort Disc
Version or Model: 5197
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 150-0197-06
Company Name: Semler Technologies, Inc.

Primary DI Number: 10815614020200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042075700 *Terms of Use

Device Description: The CompressAR Oval (Elliptical) Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5197 is an oval (ellliptical) disc with upturned edges (1.75” x 2.5").

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?
47927	Femoral artery compression system, manual, single-use	A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure; it may in addition be used on brachial and radial arteries or after venipuncture. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	Instruments, Surgical, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K891000	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: c1cb5fa9-3c61-42d2-be38-53ce1551cbe1
Public Version Date: October 16, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016