O&P Collection Vials Total Fix/C&S Kits 890-24

GUDID M445890240

Convenience kit containing C&S Vials and Total Fix Vials.

MEDICAL CHEMICAL CORPORATION

Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic Fixative, metallic

• Primary Device ID: M445890240
• NIH Device Record Key: 73b8f380-14fc-4ee2-946c-1cbd623e4303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O&P Collection Vials Total Fix/C&S Kits
• Version Model Number: 890-24
• Catalog Number: 890-24
• Company DUNS: 008496861
• Company Name: MEDICAL CHEMICAL CORPORATION
• Device Count: 50
• 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	M445890240 [Unit of Use]
HIBCC	M445890241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150887

FDA Product Code

• LDX: Fixative, Metallic Containing

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