Closed Wound Suction - CWS 400 Closed Wound Suction Kit, Small 3/32" (7 - C. R. Bard, Inc.

Duns Number:016898496

Device Description: CWS 400 Closed Wound Suction Kit, Small 3/32" (7 Fr., 2.3mm) O.D. PVC Drain, 12.5" (31.7cm CWS 400 Closed Wound Suction Kit, Small 3/32" (7 Fr., 2.3mm) O.D. PVC Drain, 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, Attached Trocar, 400cc Evacuator, 3-spring, Y-connecting Tube

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More Product Details

Catalog Number

0043600

Brand Name

Closed Wound Suction

Version/Model Number

0043600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Record Status

Public Device Record Key

267f3b9d-5afa-4084-8573-08b45f2eb8ce

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

10801741049344

Quantity per Package

5

Contains DI Package

00801741049347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"C. R. BARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 472
2 A medical device with a moderate to high risk that requires special controls. 1994
U Unclassified 10