AccessGUDID - DEVICE: HEADSTAR (04711402230280)

GUDID

Device Identifier (DI) Information

Brand Name: HEADSTAR
Version or Model: HS-9288AP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEADSTAR MEDICAL PRODUCTS CO., LTD.

Primary DI Number: 04711402230280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658122049 *Terms of Use

Device Description: SILICONE RESUSCITATOR BAG ADULT With POP OFF (With HS Logo) AUTOCLAVE TO 121 Degree C MATERIAL : PC ONE PC PER BAG, TEN PC PER CTN With INSTRUCTION BOOKLET

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?
17591	Pulmonary resuscitator, manual, reusable	A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTM	Ventilator, Emergency, Manual (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002846	000

Device Exempt from Premarket Submission: No 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: a395b6e5-c5fa-4919-a4ab-5523c926bbc9
Public Version Date: April 03, 2020
Public Version Number: 1
DI Record Publish Date: March 26, 2020