AccessGUDID - DEVICE: Healthline, ARK - Asthma Rescue Kit, Mix & Mount (00857863007758)

GUDID

Device Identifier (DI) Information

Brand Name: Healthline, ARK - Asthma Rescue Kit, Mix & Mount
Version or Model: ARK-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medi/Nuclear Corporation, Inc.

Primary DI Number: 00857863007758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079628327 *Terms of Use

Device Description: Asthma Rescue Kit, Pediatric, Bacteria Filter, w/ Mix & Mount Body

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?
31309	Nebulizing system delivery set, single-use	A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960397	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
Special Storage Condition, Specify: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6ec4969-8d91-4683-94e8-21ca2e824cd2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 09, 2017