FDA.reportPublic FDA data

Accu-Chek Inform II Instrument with RF card

Primary DI
04015630945757
Brand
Accu-Chek Inform II Instrument with RF card
Company
Roche Diagnostics GmbH
Model
04882458001
Catalog number
04882458001
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121679000ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics2012-10-11NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630945757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630945757040156309457574015630945757

GMDN Terms#

Term, Definition table
TermDefinition
Point-of-care blood glucose monitoring systemAn assembly of devices intended to be operated by a healthcare professional to continually measure patient blood glucose at the point-of-care in a healthcare facility. It is continuously connected to the patient during use and typically consists of a line-powered control unit, with user interface and rechargeable battery, containing a spectrometer to quantitatively measure glucose concentration in received plasma samples; a sterile, single-use cartridge connected to the patient via a venous catheter designed to withdraw a blood sample at intervals, convert it to plasma, and transport it to the control unit for analysis; a heparin syringe; and a sterile cap to protect the patient connector.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Kit
true
Serial number
true

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