AccessGUDID - DEVICE: ADAMII (08809317540627)

GUDID

Device Identifier (DI) Information

Brand Name: ADAMII
Version or Model: ADAMII
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317540627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687910463 *Terms of Use

Device Description: ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.

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:	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?
35476	Haematological cell analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, Differential Cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK180283	0

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: 0a0a438f-54dc-48b5-8a8f-6d32fccd7665
Public Version Date: July 23, 2024
Public Version Number: 4
DI Record Publish Date: September 02, 2020