AccessGUDID - DEVICE: nSpire Health (10852417003689)

GUDID

Device Identifier (DI) Information

Brand Name: nSpire Health
Version or Model: KoKo Filter Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K022462
Company Name: NSPIRE HEALTH, INC.

Primary DI Number: 10852417003689
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 184817096 *Terms of Use

Device Description: KoKo Pulmonary Function Filter Kit, White with Rubber Mouthpiece for KoKo Px, HDpft and Collins PFT Systems.

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:	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?
60506	Pulmonary function testing kit	A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYP	Mouthpiece, Breathing
CAH	Filter, Bacterial, Breathing-Circuit

FDA Premarket Submission

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

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: ded738e0-3b3a-4a86-8ff3-4cd9263dfeb5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016