AIV BC10969

GUDID M745BC10969

Patient Pendant Bolus Cable

AMERICAN IV PRODUCTS, INC.

Patient-controlled analgesia infusion pump
Primary Device IDM745BC10969
NIH Device Record Keyeb8c2d4f-3cfa-4692-86c7-91e1fb87a330
Commercial Distribution Discontinuation2019-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAIV
Version Model NumberBC10969
Catalog NumberBC10969
Company DUNS181184474
Company NameAMERICAN IV 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter0.17 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM745BC10969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-26
Device Publish Date2016-09-02

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