Urological Drainage Bag

GUDID 10848340020336

Urologic Drain Bag

ADVANCE MEDICAL DESIGNS, INC.

Extracorporeal circuit waste bag
Primary Device ID10848340020336
NIH Device Record Keyf75e2eff-652a-483f-8b34-4c6d19c71e82
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrological Drainage Bag
Version Model Number08-CC166
Company DUNS130785884
Company NameADVANCE MEDICAL DESIGNS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340020339 [Primary]
GS110848340020336 [Package]
Contains: 00848340020339
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


[10848340020336]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-26
Device Publish Date2024-03-18

On-Brand Devices [Urological Drainage Bag]

10848340010023Disposable Urological Drainage Device
10848340020343Urologic Drain Bag
10848340020336Urologic Drain Bag

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