Nimbus II PainPRO

GUDID 10817170020083

Ambulatory infusion pump

INFUTRONIX LLC

Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump

Primary Device ID	10817170020083
NIH Device Record Key	ed7228c2-30ff-43b7-8e32-c000d99cfa81
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nimbus II PainPRO
Version Model Number	Nimbus II PainPRO
Company DUNS	079821136
Company Name	INFUTRONIX LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817170020086 [Primary]
GS1	10817170020083 [Package] Contains: 00817170020086 Package: Inner Pack [24 Units] In Commercial Distribution
GS1	20817170020080 [Package] Contains: 00817170020086 Package: Inner pack [2 Units] In Commercial Distribution
GS1	30817170020087 [Package] Contains: 00817170020086 Package: Case [36 Units] In Commercial Distribution
GS1	40817170020084 [Package] Contains: 00817170020086 Package: Case [18 Units] In Commercial Distribution
GS1	50817170020081 [Package] Contains: 00817170020086 Package: Inner Pack [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153193

FDA Product Code

MEA	Pump, Infusion, Pca

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-10-29
Device Publish Date	2017-05-22

Devices Manufactured by INFUTRONIX LLC

00817170020376 - Nimbus II EpiD	2020-09-10 Ambulatory infusion pump
20817170020165 - Nimbus II Plus	2019-03-14 Ambulatory infusion pump
00817170020154 - Nimbus	2019-02-15 This is a plastic box outside a drug bag less than or equal to 100ml.
10817170020083 - Nimbus II PainPRO	2018-10-29Ambulatory infusion pump
10817170020083 - Nimbus II PainPRO	2018-10-29 Ambulatory infusion pump
40817170020046 - Nimbus	2018-07-06 Administration set
10817170020090 - Nimbus II Flex	2018-07-06 Ambulatory infusion pump
10817170020106 - Nimbus	2018-07-06 Ambulaotry infusion pump
10817170020007 - Nimbus	2018-03-29 Ambulatory infusion pump