FDA.reportPublic FDA data

NA

Primary DI
04046964327681
Brand
NA
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
610378
Catalog number
610378
Device description
5F MPK 4CM NDL-018 NT GW SS TIP-STD
Published
2016-08-09
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964327681PrimaryGS10
04046964327667Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964327681040469643276814046964327681
04046964327667040469643276674046964327667

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Store at room temp
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
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
04046961018650ACCEL®6223906223902026-03-16
04046955638499ACCEL®6139026139022024-05-12
04046955638475ACCEL®6139016139012024-05-12
04046955638406ACCEL®6139036139032024-05-12
04046955638529ACCEL®6139046139042024-05-12
04046955638543ACCEL®6139056139052024-05-12
04046955638567ACCEL®6139066139062024-05-12
04046955638581ACCEL®6139076139072024-05-12
04046955638604ACCEL®6139086139082024-05-12
04046955638628ACCEL®6139096139092024-05-12
04046955638642ACCEL®6139106139102024-05-12
04046955638666ACCEL®6139116139112024-05-12
04046955638680ACCEL®6139126139122024-05-12
04046955638703ACCEL®6139136139132024-05-12
04046955638727ACCEL®6139146139142024-05-12
04046955638741ACCEL®6139156139152024-05-12
04046955638765ACCEL®6139166139162024-05-12
04046955638789ACCEL®6139176139172024-05-12
04046955638802ACCEL®6139186139182024-05-12
04046955638826ACCEL®6139196139192024-05-12

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10884450441746Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441753Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441623Evolution® RLMerit Medical Systems, Inc.DRE2026-03-10
10884450441777SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441791SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441807SteadySheath® ShortieMerit Medical Systems, Inc.DRE2026-03-06
10884450441760Evolution® Shortie RLMerit Medical Systems, Inc.DRE2026-03-05
20884450707795Prelude®Merit Medical Systems, Inc.DRE2026-02-14
08033178019545PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019552PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019576PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019583PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019590PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
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10884450847265Merit MAK Gold™Merit Medical Systems, Inc.DRE2025-08-05
20884450076730Prelude® PROMerit Medical Systems, Inc.DRE2025-07-24
10884450847340Merit S-MAK™Merit Medical Systems, Inc.DRE2025-07-16