AccessGUDID - DEVICE: HEADSTAR (04711402231263)

GUDID

Device Identifier (DI) Information

Brand Name: HEADSTAR
Version or Model: HS-8800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEADSTAR MEDICAL PRODUCTS CO., LTD.

Primary DI Number: 04711402231263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658122049 *Terms of Use

Device Description: Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #0 Silicone mask for small Infant Headstar offers anatomically designed face mask that brings maximum comfort to the patient.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	No
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?
36066	Cardiopulmonary resuscitation mask, reusable	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	Mask, Oxygen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: eebfa403-c769-48d0-bfbc-25afe6e53ec9
Public Version Date: June 04, 2020
Public Version Number: 1
DI Record Publish Date: May 27, 2020