510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Optum Distribution Center, LLC

Marietta, GA, US

Optum Distribution Center, LLC appears in FDA device records in Marietta, GA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Optum Distribution Center, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Optumhealth Care Solutions, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Optum Distribution Center, LLC in 2013.

Clearances by year, as a table
510(k) clearance decisions for Optum Distribution Center, LLC, by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130971OPTUM TELEHEALTH APPLICATIONDRGSubstantially Equivalent

Registered establishments

FDA registered establishments for Optum Distribution Center, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30094569233009456923Optum Distribution Center, LLC877 Franklin Rd, Marietta, GA 30067 US2026and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1811-2024Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion PumpNimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.Class IOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain