AccessGUDID - DEVICE: Accu-Chek Inform II Instrument with RF card (04015630925469)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Chek Inform II Instrument with RF card
Version or Model: 5060303001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5060303001
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630925469
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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):	Yes
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?
56669	Metabolic profile clinical chemistry analyser IVD, stationary, automated	A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2)], electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and complete automation of all procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121679	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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e94d14bd-87a9-4755-9055-4032b786202a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016