FDA.reportPublic FDA data

JAZZ

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135037813013503781JAZZ IMAGING1N2026-01-011710 Zanker Rd San Jose CA US 95112

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00867359000309Solo - 10-001567-234-5299info@jazzimaging.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2064861868474638K241495Jazz ClassicLLZ2024-11-21
2064861846945894K213637JAZZ Solo sensorMUH2021-12-10
2064861296565418K163224JAZZ SOLO SensorMUH2017-03-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUH22021-12-10
LLZ12024-11-21

NDC#

Xyrem

Jazz Pharmaceuticals, Inc.

sodium oxybate

XYWAV

Jazz Pharmaceuticals, Inc.

calcium, magnesium, potassium, and sodium oxybates

MODEYSO

Jazz Pharmaceuticals, Inc.

dordaviprone

ZEPZELCA

Jazz Pharmaceuticals, Inc.

Lurbinectedin

VYXEOS

Jazz Pharmaceuticals, Inc.

(daunorubicin and cytarabine) liposome

DEFITELIO

Jazz Pharmaceuticals, Inc.

defibrotide sodium

Rylaze

Jazz Pharmaceuticals, Inc.

asparaginase erwinia chrysanthemi (recombinant)-rywn

ZIIHERA

Jazz Pharmaceuticals, Inc.

zanidatamab-hrii

Epidiolex

Jazz Pharmaceuticals, Inc.

cannabidiol

PMN#

Applications#

GUDID#