seca mBCA 549 - Hand-rail with medical body composition analyzer - seca GmbH & Co. KG

Duns Number:316584937

Device Description: Hand-rail with medical body composition analyzer

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More Product Details

Catalog Number

5490033009

Brand Name

seca mBCA 549

Version/Model Number

549

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUH

Product Code Name

Analyzer, body composition, exempt

Device Record Status

Public Device Record Key

2763a80c-ccbd-461e-86a8-721e37846e88

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SECA GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 29
U Unclassified 3