FDA.report

IV START KIT

Primary DI
M57257028311
Brand
IV START KIT
Company
STRADIS MEDICAL LLC
Model
570-2831
Device description
PREP AREA FOR A NEW OR REPLACEMENT IV
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OFXGeneral Purpose Dental Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M57257028311PrimaryHIBCC0

GMDN Terms

TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
043537671
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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M752BRF060MSP201DC5Stradis Medical, LLC.BRF-060MSP201DC2019-08-01
M752CD22005Stradis Medical, LLCCD-22002019-08-29
M752DC5485Stradis Medical, LLC.DC-5482019-12-20
M752DC8903CP25Stradis Medical, LLCDC8903CP-22021-09-01
M752IM12675Stradis Medical, LLC.IM12672020-06-12
M752MSDCC183000DRESSING CHANGE TRAYMSDC-C183002022-05-16
M752HCT5975OKB0Stradis Medical, LLC.HCT5975OK-B2021-04-09
M752HCT7478PIV2A5Stradis Medical, LLC.HCT7478PIV2A2021-04-21
M752HCT8428CP25Stradis Medical, LLC.HCT8428CP-22020-11-23
M752HCT984915Stradis Medical, LLC.HCT9849-12020-06-08
M75257029021PATIENT PACK NSU V2570-29022022-05-03
M752HCT200GDBP5Stradis Medical, LLCHCT200GD-BP2021-10-06
M752RWM69KTA015Stradis Medical, LLCRWM-69K-TA012021-09-30
M752WC2505Stradis Medical, LLC.WC-2502021-08-23
M752HCT354822Stradis Medical, LLCHCT3548-22021-08-13
M752ZZ09585Stradis Medical, LLCZZ-09582021-07-27

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