AccessGUDID - DEVICE: BREEZE® APD (00884908138399)

GUDID

Device Identifier (DI) Information

Brand Name: BREEZE® APD
Version or Model: BALPN1625S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BALPN1625S
Company Name: Medical Components, Inc.

Primary DI Number: 00884908138399
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 16F X 25CM BREEZE® ALL PURPOSE DRAIN WITH LOCKING PIGTAIL SET

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
32337	Abdominal paracentesis needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGE	Stents, drains and dilators for the biliary ducts

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
No Device Sizes

Device Record Status

Public Device Record Key: 2fb33206-b22e-4740-a949-7641524da8c4
Public Version Date: March 07, 2022
Public Version Number: 1
DI Record Publish Date: February 26, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50884908138394	20	30884908138390		In Commercial Distribution	box
30884908138390	5	00884908138399		In Commercial Distribution	inner box

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(215)256-4201
Email: clinical@medcompnet.com

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

FDA TOOLS & RESOURCES