AccessGUDID - DEVICE: Tamper Evident Cap (B21257351R1)

GUDID

Device Identifier (DI) Information

Brand Name: Tamper Evident Cap
Version or Model: 57-351 R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-351 R
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B21257351R1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: "Sterile Red Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility. Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per 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?
16825	Syringe tip cap	A device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K861276	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: 65e4ccbc-f8a7-4570-a590-d5adc244c70e
Public Version Date: February 21, 2020
Public Version Number: 1
DI Record Publish Date: February 13, 2020