Formalin / C&S / Clean Stool Collection Kits 891-20

GUDID M445891200

Convenience kit containing Formalin, C&S and Clean Vials for stool collection.

MEDICAL CHEMICAL CORPORATION

10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD 10% Neutral buffered formalin IVD

• Primary Device ID: M445891200
• NIH Device Record Key: ee97ea59-6cde-4287-8592-798ec31d1be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Formalin / C&S / Clean Stool Collection Kits
• Version Model Number: 891-20
• Catalog Number: 891-20
• Company DUNS: 008496861
• Company Name: MEDICAL CHEMICAL CORPORATION
• Device Count: 36
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M445891200 [Unit of Use]
HIBCC	M445891201 [Primary]

FDA Product Code

• IFP: Formalin, Neutral Buffered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-08
• Device Publish Date: 2020-08-31

Devices Manufactured by MEDICAL CHEMICAL CORPORATION

• M445693A50PACK1 - SED-CONNECT: 2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
• M445693AESEDEA50PACK1 - SED-CONNECT: 2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
• M445693AFUNNEL1 - SED-CONNECT: 2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
• M445693ASAMPLE1 - SED-CONNECT: 2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
• M445694A1 - MICRO-SED: 2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
• M445694AEA1 - MICRO-SED: 2021-07-08 MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This
• M445694ASAMPLE1 - MICRO-SED: 2021-07-08 MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This
• M445694ATUBEFUNNEL1 - MICRO-SED: 2021-07-08 MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This