Custom Medical Specialties, Inc.

GUDID 00815849022713

Polyvinyl Urological Drainage Bag for Skytron Systems - Non-Sterile

CUSTOM ASSEMBLIES, INC.

Surgical tissue/fluid collection bag, non-sterile
Primary Device ID00815849022713
NIH Device Record Key47af004f-cab3-4959-a024-db2a7e86ba01
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Medical Specialties, Inc.
Version Model NumberCMS-969P
Company DUNS948904735
Company NameCUSTOM ASSEMBLIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815849022706 [Primary]
GS100815849022713 [Package]
Contains: 00815849022706
Package: [20 Units]
In Commercial Distribution

FDA Product Code

BWNTable And Attachments, Operating-Room

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-22

On-Brand Devices [Custom Medical Specialties, Inc.]

0081584902322262" Straight Injection Line - Sterile
00815849023192Custom Tubing Set w/ Multi-Step Connector - Sterile
0081584902317836" x 36" Bandbag - Sterile
00815849023130Catheter Adapter - Sterile
008158490231233" IV Transfer Connecting Set - Sterile
008158490231095" x 12" Band Bag - Non-Sterile
00815849023093Instillation (BCG) Kit - Sterile
00815849023062US Probe Cover, Rolled 5" x 93" - Sterile
00815849023031Short Expandable Hose - Non-Sterile
00815849023017Urological Drainbag w/ 6mm Plug for Skytron Systems- Sterile
00815849022997Custom Tubing 48" Extension Set - Sterile
00815849022973Custom Tumescent Set - Non-Sterile
00815849022935Urology Tubing Set - Sterile
00815849022874Halstead Mosquito Forcep - Sterile
00815849022850Universal Urological Drainbag w/ 12"x12" 2ml Vented Polybag - Non-Sterile
00815849022737Universal Urological Drainage Bag w/ XL Hose - Non-Sterile
00815849022713Polyvinyl Urological Drainage Bag for Skytron Systems - Non-Sterile
00815849022690Vinyl Acetate Urological Drainage Bag for Dornier Systems - Non-Sterile
00815849022676Vinyl Acetate Urological Drainage Bag for Skytron Systems w/ 8mm Plug - Non-Sterile
00815849022652Polyvinyl Urological Drainage Bag for Skytron Systems w/ 10mm Plug - Non-Sterile
00815849022638Vinyl Acetate Urological Drainage Bag for GE/OEC Systems w/ 8mm Plug - Non-Sterile
00815849022614Polyvinyl Urological Drainage Bag for GE/OEC Systems w/ 10mm Plug - Non-Sterile
00815849022591Vinyl Acetate Urological Drainage Bag for Liebel/OEC Systems w/ 6mm Plug - Non-Sterile
00815849022577Vinyl Acetate Urological Drainage Bag for Siemens Systems w/ 6mm Plug - Non-Sterile
00815849022553Polyvinyl Urological Drainage Bag for Siemens Systems w/ XL Hose - Non-Sterile
00815849022539Polyvinyl Urological Drainage Bag for Siemens Systems w/ 6mm Plug - Non-Sterile
00815849022515Polyvinyl Urological Drainage Bag for Siemens Systems w/ 10mm Plug - Non-Sterile
0081584902249272" Drainbag Hose - Non-Sterile
00815849022478Collection Bag Y-Connector - Non-Sterile
00815849022454Large Suction Tubing - Sterile
00815849022430Universal Urological Drainage Bag w/ 8mm Plug - Sterile
00815849022416Universal Urological Drainage Bag w/ 6mm Plug - Sterile
00815849022393Vinyl Acetate Urological Drainage Bag for Skytron Systems w/ 8mm Plug - Sterile
00815849022379Vinyl Acetate Urological Drainage Bag for Skytron Systems - Sterile
00815849022355Polyvinyl Urological Drainage Bag for Skytron Systems w/ 6mm Plug - Sterile
00815849022331Polyvinyl Urological Drainage Bag for Skytron Systems - Sterile
10815849022314Polyvinyl Urological Drainage Bag for GE/OEC Systems - Sterile
00815849022300Vinyl Acetate Urological Drainage Bag for Liebel Systems - Sterile
00815849022287Vinyl Acetate Urological Drainage Bag for Siemens Systems - Sterile
00815849022263Polyvinyl Urological Drainage Bag for Siemens Systems - Sterile
0081584902224936" Console Cover - Sterile
0081584902222586" x 135" Femoral Drape - Sterile
00815849022201Procedure Drape - Sterile
008158490221886" x 96" Probe Cover w/ Bands and Gel - Sterile
0081584902216486" x 125" Femoral Drape - Sterile
00815849022140Fan Folded Table Cover - Sterile
00815849022126Foam Prep Sticks - Sterile
00815849022102Towel Clamp - Non-Sterile
00815849022089Custom HSG Catheter - Sterile
00815849022065Angled Prep Stick - Non-Sterile
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