AccessGUDID - DEVICE: Denver (10885403076039)

GUDID

Device Identifier (DI) Information

Brand Name: Denver
Version or Model: 42-2322
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42-2322
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403076039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: Denver Venous Catheter, 15.5 Fr. x 27 cm

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13589	Peritoneovenous shunt	A sterile, surgically implanted, subcutaneous plastic tube used to continuously drain ascites fluid from the peritoneal cavity to the jugular vein. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KPM	Shunt, Peritoneal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 27 Centimeter
Catheter Gauge: 15.5 French

Device Record Status

Public Device Record Key: 1d2f8f0f-f4d2-4706-af48-3780ef957a59
Public Version Date: November 13, 2019
Public Version Number: 3
DI Record Publish Date: June 12, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50885403076037	5	10885403076039		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)323-9088
Email: gmb-MedSpec-CustService@carefusion.com

Phone: +1(800)323-9088
Email: Customer_Support@BD.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES