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Codonics Safe Label System®(SLS) 500i Point of Care Station

FDA UDI

Class II (US FDA UDI)

by Codonics Inc.

Identity

Trade Name
Codonics Safe Label System®(SLS) 500i Point of Care Station FDA UDI
Generic Name
Parenteral-nutrition management software FDA UDI
Device Name
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C FDA UDI
Model / Reference
500i PCS -140C FDA UDI
Description
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C FDA UDI

Identifiers

Primary DI / UDI-DI
00814905020236 FDA UDI
510(k) Number
K101439 FDA UDI
FDA Product Code
BSZ FDA UDI
GMDN Term
Parenteral-nutrition management software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station by Codonics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Parenteral-nutrition management software.

Cleared under the same submission

K101439 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Codonics Inc.

Sources (1)

  • FDA UDI 4db16f04-2daf-460e-ad2f-bec689c9be8a 35 fields · synced Jun 1, 2026