FDA.reportPublic FDA data

UNBRANDED

Primary DI
00848340009235
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
CMS03NS
Device description
Fluid Delivery Set
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340009232PackageGS1100In Commercial Distribution
00848340009235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000923210848340009232
00848340009235008483400092358483400092350848340009235

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/gas irrigatorA sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848340018213Urological Drainage BagKTEK84112026-05-07
00848340018220Urological Drainage BagKYRA84102026-04-15
00848340018206Urological Drainage BagKTEK84102026-04-13
00848340010712C-FlexA-707022026-03-12
10848340010719C-FlexA-707022026-03-12
00848340014857Asonic GelASG-0012023-06-13
00848340002212Transducer Cover05-TC9962024-02-05
00848340002229Custom Cover08-CC1242024-02-06
00848340002236Custom Cover08-CC1342024-02-07
00848340002243Custom Cover08-CC1372024-02-07
00848340002250Custom Cover08-CC1392024-02-08
00848340002267Custom Cover08-CC1402024-02-08
00848340002281Camera Cover08-CC1492024-02-12
00848340002298Cassette Drape08-CC1502024-02-15
00848340002311Snap Kover08-CC1622024-02-15
00848340002328Custom Pack08-CC1632024-02-15
00848340002335Custom Pack08-CC1702024-02-20
00848340002342Positioning Arm Drape08-CU15612024-02-21
00848340002359Doppler Flow Wire CoverDFC1002024-03-13
00848340002366Doppler Flow Wire CoverDFC1012024-03-13

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07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
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07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
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