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Phosphate Buffered Saline with Ca, Mg, Glucose, Pyrovate, Phenol Red

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Phosphate Buffered Saline with Ca, Mg, Glucose, Pyrovate, Phenol Red FDA UDI
Generic Name
IVF medium FDA UDI
Device Name
Phosphate Buffered Saline with Ca, Mg, Glucose, Pyrovate, Phenol Red. 500 ml FDA UDI
Model / Reference
ART-4012 FDA UDI
Description
Phosphate Buffered Saline with Ca, Mg, Glucose, Pyrovate, Phenol Red. 500 ml FDA UDI

Identifiers

Primary DI / UDI-DI
00888937819069 FDA UDI
FDA Product Code
MQL FDA UDI
GMDN Term
IVF medium FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6180 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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

Category: IVF medium

Phosphate Buffered Saline with Ca, Mg, Glucose, Pyrovate, Phenol Red by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as IVF medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI fd42b8c2-d063-4319-90fb-b2b2a3155027 34 fields · synced Jun 9, 2026