Parallel 1.8m (71") Circuit + Mon Line + Luer Elbow + 3L Res Bag + 1m Limb + Bag - Parallel 1.8m (71") Circuit + Mon Line + Luer - FLEXICARE MEDICAL LIMITED

Duns Number:504406273

Device Description: Parallel 1.8m (71") Circuit + Mon Line + Luer Elbow + 3L Res Bag + 1m Limb + Bag Arm(038-0 Parallel 1.8m (71") Circuit + Mon Line + Luer Elbow + 3L Res Bag + 1m Limb + Bag Arm(038-01-110/1GE)

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More Product Details

Catalog Number

-

Brand Name

Parallel 1.8m (71") Circuit + Mon Line + Luer Elbow + 3L Res Bag + 1m Limb + Bag

Version/Model Number

2105488-013

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

Yes

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

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Device Record Status

Public Device Record Key

0a4788d8-7e75-4065-9c4f-62fdbe468aad

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXICARE MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 715
2 A medical device with a moderate to high risk that requires special controls. 465