AccessGUDID - DEVICE: VasoStat Hemostasis Device (00863879000201)

GUDID

Device Identifier (DI) Information

Brand Name: VasoStat Hemostasis Device
Version or Model: 10348-325-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Forge Medical, Inc.

Primary DI Number: 00863879000201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071018368 *Terms of Use

Device Description: The VasoStat Hemostasis Device is used to augment hemostasis through a ratcheting pressure mechanism.

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 [?]
K153259	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
Special Storage Condition, Specify: Store in a dark, dry, cool place. Avoid extended exposure to light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1595749-a213-410c-871c-e7e31950527f
Public Version Date: June 06, 2023
Public Version Number: 3
DI Record Publish Date: May 27, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10863879000208	10	00863879000201	In Commercial Distribution	Carton
20863879000205	1	10863879000208	In Commercial Distribution	Shipper
30863879000202	2	10863879000208	In Commercial Distribution	Shipper
40863879000209	3	10863879000208	In Commercial Distribution	Shipper
50863879000206	4	10863879000208	In Commercial Distribution	Shipper