AccessGUDID - DEVICE: Envision Transducer Cover (10841436120590)

GUDID

Device Identifier (DI) Information

Brand Name: Envision Transducer Cover
Version or Model: H2O-015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H2O-015, H2O-015-5
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 10841436120590
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Sterile (14x30cm) CIV-flex cover with Enviision

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:	Yes
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?
44713	Body-surface ultrasound imaging transducer cover	A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190802	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 14 Centimeter
Width: 30 Centimeter

Device Record Status

Public Device Record Key: bd5a35ce-2a1e-46c0-8c49-582f91dc39c3
Public Version Date: September 06, 2021
Public Version Number: 2
DI Record Publish Date: January 21, 2021