AccessGUDID - DEVICE: SecurePortIV (M495SP015V2)

GUDID

Device Identifier (DI) Information

Brand Name: SecurePortIV
Version or Model: SP-015V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP-015V
Company Name: ADHEZION BIOMEDICAL, LLC

Primary DI Number: M495SP015V2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 827716437 *Terms of Use

Device Description: SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry.

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:	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?
56631	Wearable percutaneous catheter/tube holder	A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZP	Sealant, Microbial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170505	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
Storage Environment Temperature: less than 86 Degrees Fahrenheit
Special Storage Condition, Specify: Recommended storage: away from moisture, direct heat, or direct light

Clinically Relevant Size

[?]

Size Type Text
Total Volume: .15 Milliliter

Device Record Status

Public Device Record Key: e08aa6db-94ca-485a-bb30-a45b68f6f4d1
Public Version Date: July 22, 2019
Public Version Number: 6
DI Record Publish Date: February 05, 2018