DEVICE: Nimbus (00817170020154)

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Device Record History
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Device Identifier (DI) Information
Nimbus
Nimbus Hard Shell 100ml
In Commercial Distribution

INFUTRONIX LLC
00817170020154
GS1

1
079821136 *Terms of Use
This is a plastic box outside a drug bag less than or equal to 100ml.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35932 Patient-controlled analgesia infusion pump
A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.
Obsolete false
61514 Ambulatory non-insulin infusion pump, electronic
A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MEA Pump, Infusion, Pca
FRN Pump, Infusion
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K153193 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7479b77b-628b-4904-b6ed-5306400ba2c1
August 07, 2024
4
January 15, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20817170020158 80 00817170020154 In Commercial Distribution Case
10817170020151 20 00817170020154 In Commercial Distribution Inner Pack
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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