Battery Pack, Kls-Sd-2000, Single

FDA UDI

Class I (US FDA UDI)

by Pro-Dex, Inc.

Identity

Trade Name: BATTERY PACK, KLS-SD-2000, SINGLE FDA UDI
Generic Name: Disposable battery pack FDA UDI
Model / Reference: KLS-BP2-001 FDA UDI

Identifiers

Primary DI / UDI-DI: 00856482008122 FDA UDI
FDA Product Code: HWE FDA UDI
GEY FDA UDI
GXL FDA UDI
GMDN Term: Disposable battery pack FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
882.4900 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Disposable battery pack

Battery Pack, Kls-Sd-2000, Single by Pro-Dex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Pro-Dex, Inc.

Sources (1)

FDA UDI 5ddff79b-a6a9-4c8e-9ea6-68b5b4cecc2d 32 fields · synced May 31, 2026