AccessGUDID - DEVICE: Tamper Evident Cap with Male Luer Lock (B2125791R1)

GUDID

Device Identifier (DI) Information

Brand Name: Tamper Evident Cap with Male Luer Lock
Version or Model: 57-91 R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-91 R
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B2125791R1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box

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?
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182545	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: 32ea9297-7f9e-4e3d-b5d0-9b9a0dd44287
Public Version Date: April 07, 2021
Public Version Number: 2
DI Record Publish Date: February 13, 2020