FDA.reportPublic FDA data

Ster-ASSIST ™

Primary DI
04046964712814
Brand
Ster-ASSIST ™
Company
B. BRAUN MEDICAL INC.
Model
375502
Catalog number
375502
Device description
Introcan Safety® 20 Ga. x 1.75 in ., Straight, FEP and CARESITE® Extension Set with bonded CARESITE Luer Access Device, Spin-Lock® connector, 8 in. (20cm). Fo r use with power injector
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWLPeripheral catheter insertion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964712814PrimaryGS10
04046964712807Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964712814040469647128144046964712814
04046964712807040469647128074046964712807

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30849884007474VYGONVygon CorporationOWL2026-03-06
30849884007320VYGONVygon CorporationOWL2026-02-11
50198956291667CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
50198956188127CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
50198956266665CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
50198956263558CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
50198956257113CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
50198956184457CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
50198956165432CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
20809160486389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OWL2025-07-22
50197106694808CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10661392007663LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392007830LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
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10661392025759LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392025827LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027548LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027555LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027678LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392028309LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037899LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037981LSL HEALTHCARELSL Industries, LLCOWL2025-05-16