AccessGUDID - DEVICE: Tamper Evident Cap for use with ENFit Syringes (B21257220R1)

GUDID

Device Identifier (DI) Information

Brand Name: Tamper Evident Cap for use with ENFit Syringes
Version or Model: 57-220 R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-220 R
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B21257220R1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Tamper evident cap for use with ENFit syringes; red; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence.

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
PNR	Enteral Syringes With Enteral Specific Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170672	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: e26e1a48-f5e4-4bd5-ac74-61a19a750193
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 29, 2018