Exactamix

FDA UDI

Class II (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name: EXACTAMIX FDA UDI
Generic Name: Intravenous administration bag/bottle FDA UDI
Device Name: EXACTAMIX Empty EVA Bag FDA UDI
Model / Reference: H938739 FDA UDI
Description: EXACTAMIX Empty EVA Bag FDA UDI

Identifiers

Catalog Number: H938739 FDA UDI
Primary DI / UDI-DI: 00085412477237 FDA UDI
510(k) Number: K900585 FDA UDI
FDA Product Code: LHI FDA UDI
GMDN Term: Intravenous administration bag/bottle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1000 Milliliter FDA UDI

Category: Intravenous administration bag/bottle

Exactamix by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration bag/bottle.

Bag for enzyme replacement therapy — VALMED SRL · Class IIa
Parenteral nutrition bag — VALMED SRL · Class IIa
Parenteral nutrition bag — VALMED SRL · Class IIa
Parenteral nutrition bag — VALMED SRL · Class IIa
Parenteral nutrition bag — VALMED SRL · Class IIa
SECURE® — METRIX COMPANY, THE · Class II
Empty Fluid Container 250 ml Max Capacity (NFV Fill Port with Seal-Tab) — Epic International (Thailand) Co., Ltd. · Class I
EVA TPN Bags — Valmed Corp. · Class II

Cleared under the same submission

K900585 also covers:

EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
EXACTAMIX — Baxter Healthcare Corp
EXACTAMIX — Baxter Healthcare Corp
EXACTAMIX — Baxter Healthcare Corp
EXACTAMIX — Baxter Healthcare Corp
EXACTAMIX — Baxter Healthcare Corp
EXACTAMIX — Baxter Healthcare Corp
EXACTAMIX — Baxter Healthcare Corp

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Baxter Healthcare Corp

Sources (1)

FDA UDI d426aef2-628d-4a19-9a36-9b4f71d3737e 37 fields · synced May 29, 2026