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Mixject

FDA UDIEUDAMED

Class II (US FDA UDI)

by West Pharma. Services Il, . Ltd

Identity

Trade Name
MIXJECT FDA UDI
Generic Name
Medication transfer set FDA UDI
Device Name
MIXJECT™ 13mm w/27G Needle FDA UDI
Model / Reference
970113 FDA UDI
Description
MIXJECT™ 13mm w/27G Needle FDA UDI

Identifiers

Primary DI / UDI-DI
07290108241013 FDA UDI
510(k) Number
K963583 FDA UDI
FDA Product Code
LHI FDA UDI
GMDN Term
Medication transfer set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Mixject by West Pharma. Services Il, . Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K963583 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
West Pharma. Services Il, . Ltd

Sources (2)

  • FDA UDI d5c9ab64-2def-417b-9754-735333581d28 35 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026