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Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa

FDA UDI

Class I (US FDA UDI)

by Cygnus Medical L.l.c.

Identity

Trade Name
Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa FDA UDI
Generic Name
Endoscopy preparation kit FDA UDI
Device Name
Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Water Bowl, 10X 4X4 GAUZE AND 2 OZ LUBE, 1 Kit FDA UDI
Model / Reference
BNK-T-BBHJ-PAD-M FDA UDI
Description
Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Water Bowl, 10X 4X4 GAUZE AND 2 OZ LUBE, 1 Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00843356101782 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Endoscopy preparation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopy preparation kit

Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Endoscopy preparation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 0d6469e4-d18d-47dd-a8f1-9edde733d67d 33 fields · synced May 30, 2026