FDA.reportPublic FDA data

Sterimed

Primary DI
00860001790276
Brand
Sterimed
Company
STERIMED LLC
Model
DB3000
Device description
Drain bag for Skytron/Liebel Tables
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYHTable, Cysto, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYHTable, Cysto, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860001790273PackageGS120In Commercial Distribution
00860001790276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000179027310860001790273
00860001790276008600017902768600017902760860001790276

GMDN Terms#

Term, Definition table
TermDefinition
Urological fluid funnelA device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
770-387-0771xx@xx.xx

Regulatory Flags#

DUNS number
080284658
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850341007349SterimedMB00622016-09-19
00850341007356SterimedMB00962016-09-19
00850341007363SterimedMG01052016-09-19
00850341007370SterimedMR00822016-09-19
00850341007387SterimedMR01202016-09-19
00850341007394SterimedPB10032016-09-19
00850341007479SterimedWG01052016-09-19
00850341007486SterimedWR01202016-09-19
00850341007493SterimedWR01502016-09-19
00850341007509SterimedWR10102016-09-19
00850341007516SterimedZB10052016-09-19
00850341007523SterimedZG00822016-09-19
00850341007752SterimedMR01502016-09-19
00850341007776SterimedTR0105B2016-09-19
00850341007790SterimedZB00962016-09-19
00850341007806SterimedZG10012016-09-19
00850341007813SterimedZG10062016-09-19
00850341007905SterimedZG10072016-09-19
00860001790207Sterimed0888NT0888NT2019-05-16
00860001790214Sterimed3520SB2020-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07467423230569SterimedDAS Medical International SRLEYH2025-12-11
07467423230576SterimedDAS Medical International SRLEYH2025-12-11
07467423230606SterimedDAS Medical International SRLEYH2025-12-11
07467423230613SterimedDAS Medical International SRLEYH2025-12-11
07467423230620SterimedDAS Medical International SRLEYH2025-12-11
17467423230566SterimedDAS Medical International SRLEYH2025-12-11
17467423230573SterimedDAS Medical International SRLEYH2025-12-11
17467423230603SterimedDAS Medical International SRLEYH2025-12-11
17467423230610SterimedDAS Medical International SRLEYH2025-12-11
17467423230627SterimedDAS Medical International SRLEYH2025-12-11
07467423230651SterimedDAS Medical International SRLEYH2025-12-08
17467423230658SterimedDAS Medical International SRLEYH2025-12-08
00749756629164DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
00749756629171DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
00749756629188DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629169DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629176DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629183DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
07466532979116SchaererDAS Medical International SRLEYH2021-05-03
17466532979113SchaererDAS Medical International SRLEYH2021-05-03
00860001790221SterimedSTERIMED LLCEYH2020-09-21
00860001790238SterimedSTERIMED LLCEYH2020-09-21
00860001790245SterimedSTERIMED LLCEYH2020-09-21
00860001790252SterimedSTERIMED LLCEYH2020-09-21
00860001790269SterimedSTERIMED LLCEYH2020-09-21
00860001790283SterimedSTERIMED LLCEYH2020-09-21
10860001790228SterimedSTERIMED LLCEYH2020-09-21
10860001790235SterimedSTERIMED LLCEYH2020-09-21
10860001790242SterimedSTERIMED LLCEYH2020-09-21
10860001790259SterimedSTERIMED LLCEYH2020-09-21