What is FDA product code FDA?

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticEnteroscope And Accessories

HealthMart

Name: HealthMart
Brand: HealthMart

Catalogue number BP3NG1-1AHM, listed by Strategic Sourcing Services LLC, under Enteroscope And Accessories. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Liaoning. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FDA
Manufacturer	City	Province	Registered as	Device types
Dalian Create Medical Products Co., Ltd.	Dalian	Liaoning	Contract manufacturer	2

Record

Regulatory record for HealthMart
Listed by	Strategic Sourcing Services LLC
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Record published	2020-07-31
Record revised	2020-08-27 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number
Packaging	Pack of 6

Catalogue Numbers

Catalogue numbers for HealthMart
Catalogue number	Size	Status
BP3NG1-1AHM		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fujifilm	Fujifilm Corporation	6
Cardinal Health	Cardinal Health 200, LLC	2
Balloon Control Unit	Olympus Medical Systems Corp.	2
Q Urological Persistent Aguamedicina	Q Urological Corporation	2
Evis Exera II Small Intestinal Videoscope	Olympus Medical Systems Corp.	2
Endoscope Position Detecting Unit	Olympus Medical Systems Corp.	2
CD138 + Cyclin D1	Biocare Medical, LLC	1
TG-98 LM Synea 400	W&H Dentalwerk Bürmoos GmbH	1
Ancora	Aspero Medical, Inc.	1
Zeus-P	Spinal Elements, Inc.	1
Jade PTA Balloon Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	1
Premier Jackson Improved Short Tracheostomy Tube	Premier Dental Products Co.	1

Showing 12 of 19. All products under Enteroscope And Accessories

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.