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MediBag

FDA UDI

Class II (US FDA UDI)

by Summit Medical Products, Inc.

Identity

Trade Name
MediBag FDA UDI
Generic Name
Parenteral/enteral solution bag FDA UDI
Device Name
MediBag-250 mL Dual Port (Needleless and Spike Ports) FDA UDI
Model / Reference
220529 FDA UDI
Description
MediBag-250 mL Dual Port (Needleless and Spike Ports) FDA UDI

Identifiers

Catalog Number
220529 FDA UDI
Primary DI / UDI-DI
00857595005831 FDA UDI
510(k) Number
K001287 FDA UDI
FDA Product Code
KPE FDA UDI
GMDN Term
Parenteral/enteral solution bag FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5025 FDA UDI
Commercial Distribution
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

Dimensions & Sizes

Size
Total Volume — 250 Milliliter FDA UDI

Category: Parenteral/enteral solution bag

MediBag by Summit Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Parenteral/enteral solution bag.

Cleared under the same submission

K001287 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Medical Products, Inc.

Sources (1)

  • FDA UDI d61f2f75-e861-4024-b384-52dbc7b93dac 37 fields · synced May 30, 2026