AccessGUDID - DEVICE: MICRO-SED (M445694AEA1)

GUDID

Device Identifier (DI) Information

Brand Name: MICRO-SED
Version or Model: 694A-EA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 694A-EA
Company Name: MEDICAL CHEMICAL CORPORATION

Primary DI Number: M445694AEA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 008496861 *Terms of Use

Device Description: MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 50 sets of single use components.

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:	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?
57939	Faecal parasite specimen concentration kit IVD	A collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKS	Device, Parasite Concentration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941129	000

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: 8af141b7-cbc0-4c22-8ede-16640b8381af
Public Version Date: July 08, 2021
Public Version Number: 4
DI Record Publish Date: September 20, 2016