Ostomy Bag (Non-sterile) Medical Device Identification

GUDID 16974795050247

Ostomy Bag (Non-sterile)

Henan Maidingkang Medical Technology Co., Ltd.

One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended

Primary Device ID	16974795050247
NIH Device Record Key	65fbfcad-c90f-4e06-b5ca-c636652bcee2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	Non-Sterile
Company DUNS	724981491
Company Name	Henan Maidingkang Medical Technology Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974795050240 [Primary]
GS1	16974795050247 [Package] Contains: 06974795050240 Package: [40 Units] In Commercial Distribution

FDA Product Code

EXG	Bag, Urine Collecting, Ureterostomy

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	2022-06-13
Device Publish Date	2022-06-03

Devices Manufactured by Henan Maidingkang Medical Technology Co., Ltd.

06974795050066 - LotFancy	2024-04-01
06974795050059 - LotFancy	2024-03-29
06974795050011 - MEDLOT	2024-01-31
06974795050028 - MEDLOT	2024-01-31
06974795050035 - MEDLOT	2024-01-31
06974795050042 - MEDLOT	2024-01-31
16974795050117 - NA	2022-06-13 Hydrocolloid Dressing (Non-sterile)
16974795050131 - NA	2022-06-13 Scar Sticker (Sterile)