Procedure Products Bag Spigot

GUDID B16047101

SPIGOT, NON-VENTED BAG 6" TUBE

PROCEDURE PRODUCTS, INC.

Intravenous fluid bag spike
Primary Device IDB16047101
NIH Device Record Key74e70bef-337c-4d9a-88b2-02e74cf12bb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Products Bag Spigot
Version Model Number4710
Company DUNS151507563
Company NamePROCEDURE PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB16047101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPEContainer, I.V.

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-12

Devices Manufactured by PROCEDURE PRODUCTS, INC.

B1601006B1 - Freedom Syringe2020-09-08 Freedom Syringe, 6cc Blue Plunger
B160B10R0721 - Procedure Products Lines2020-05-01 HIGH PRESSURE BRAIDED SWIVEL LINE, 10"
B1601001R1 - Freedom Syringe2020-03-18 Freedom Syringe, 01cc Red Plunger
B1601003G1 - Freedom Syringe2020-03-18 Freedom Syringe, 03cc Green Plunger
B1601010B1 - Freedom Syringe2020-03-18 Freedom Syringe, 10cc Blue Plunger
B1601020W1 - Freedom Syringe2020-03-18 Freedom Syringe, 20cc White Plunger
B1603118451 - Procedure Products Needle2020-03-18 NEEDLE, W/O BASEPLATE, 11CM 18g
B1605320Y1 - Procedure Products Syringe2019-10-10 10CC PALM PAD CONTROL SYRINGE, Yellow Plunger

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