AmerisourceBergen

Basic Information

• Brand Name: AmerisourceBergen
• Primary DI: 00368001115018
• Version / Model: 11501
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• Labeler DUNS: 985523874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-03-03
• Public Version: 2
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: 04309128-c8f7-4732-9311-9ddf5f135e7e

Device Description

Fecal Loops Disposable Adult Size

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15155	Inoculating tool IVD, manual	A hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80368001115014	GS1
Primary	00368001115018	GS1
Package	60368001115010	GS1	box	10	In Commercial Distribution