AccessGUDID - DEVICE: AMShield® Disinfecting Cap (30704411011860)

GUDID

Device Identifier (DI) Information

Brand Name: AMShield® Disinfecting Cap
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DCF2500S
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 30704411011860
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMShield® Disinfecting Cap Contains 70% IPA for Needle-Free Valves 10 Pieces Mounted on a Strip

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?
61141	Luer-formatted disinfection cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKB	Pad, Alcohol, Device Disinfectant

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: 0db35c64-214a-4519-9578-f3c00be916a7
Public Version Date: September 09, 2020
Public Version Number: 3
DI Record Publish Date: March 20, 2020