← Back to catalogue

BioMed 2000 XL

FDA UDI

Class II (US FDA UDI)

by BioMedical Life Systems Inc.

Identity

Trade Name
BioMed 2000 XL FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Model / Reference
2000XL FDA UDI

Identifiers

Catalog Number
KBXL FDA UDI
Primary DI / UDI-DI
00857771003149 FDA UDI
510(k) Number
K061476 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 2 Inch FDA UDI
Depth — 7 Inch FDA UDI
Height — 6 Inch FDA UDI

BioMed 2000 XL by BioMedical Life Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K061476 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
BioMedical Life Systems Inc.

Sources (1)

  • FDA UDI 62b0d279-7932-4f0d-a154-35a025fd4000 37 fields · synced May 30, 2026