Capable

Basic Information

• Brand Name: Capable
• Primary DI: 06975867555229
• Version / Model: Size 4
• Company Name: Shanghai Kabu International Trade Co., Ltd
• Labeler DUNS: 416421979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-24
• Public Version: 1
• Public Version Date: 2023-03-06
• Public Version Status: New
• Public Device Record Key: 394f3f74-cc25-4253-8cd4-c1f3565b9dc1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	876.5920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35008	Infant nappy	A disposable undergarment (nappy or diaper) composed of absorbent material intended to be worn around the perineum between the legs to collect urine and faeces for disposal from an infant or an incontinent child. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16975867555226	GS1		102	In Commercial Distribution
Primary	06975867555229	GS1