NAMIC - CIL FLEX 10 FLL-RA - PKG - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: CIL FLEX 10 FLL-RA - PKG

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More Product Details

Catalog Number

91051103

Brand Name

NAMIC

Version/Model Number

91051103

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K822100,K822100

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

bbc8026d-e804-49dd-820d-865b0f797f2d

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Additional Identifiers

Package DI Number

20193489068860

Quantity per Package

25

Contains DI Package

10193489068863

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7