AccessGUDID - DEVICE: Perfusor® (04046955083077)

GUDID

Device Identifier (DI) Information

Brand Name: Perfusor®
Version or Model: 8713330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8713330
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955083077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: SPACE LOCKBOX FOR PERFUSOR SPACE PUMPS

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
10535	Medicine cabinet	A furniture-like device designed for storing and preparing medicines. It will typically have shelves, drawers, narcotics locker, and may have other facilities, e.g., sinks or work counters. Some may even have a small built-in refrigerator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRZ	ACCESSORIES, PUMP, INFUSION

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: No
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: 48dba9ae-d710-4d24-861c-887ebb90fded
Public Version Date: February 18, 2019
Public Version Number: 1
DI Record Publish Date: January 18, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)227-2862
Email: BBMUS_Service.EmailOrders@bbraun.com

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

FDA TOOLS & RESOURCES