CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M20890027810
• Version / Model: 712057052781
• Catalog Number: 9002781
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 62d9bd9d-d5ad-4964-b0b7-498c1b093380

Device Description

DISPOSABLE MUCUS TRAP, 80 ML (CC)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYZ	Trap, Sterile Specimen	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10943	Sputum specimen container IVD	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a sputum specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M20890027812	HIBCC	50/CS	50	In Commercial Distribution
Primary	M20890027810	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	80	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: DO NOT USE IF PACKAGE IS OPEN OR DAMAGED
• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN A COOL DRY PLACE
• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius