Antistatic Compact Space Chamber with Large Mask

FDA UDI

Class II (US FDA UDI)

by Medical Developments International

Identity

Trade Name: Antistatic Compact Space Chamber with Large Mask FDA UDI
Generic Name: Medicine chamber spacer, reusable FDA UDI
Device Name: An Anti-Static Compact Space Chamber with a Large Silicone Face Mask FDA UDI
Model / Reference: SP-ANTI-SLUS FDA UDI
Description: An Anti-Static Compact Space Chamber with a Large Silicone Face Mask FDA UDI

Identifiers

Primary DI / UDI-DI: 00842135100039 FDA UDI
510(k) Number: K143615 FDA UDI
FDA Product Code: NVP FDA UDI
GMDN Term: Medicine chamber spacer, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 14.5 Centimeter FDA UDI
Total Volume — 160 Milliliter FDA UDI

Category: Medicine chamber spacer, reusable

Antistatic Compact Space Chamber with Large Mask by Medical Developments International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K143615 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Medical Developments International

Sources (1)

FDA UDI 90a364e7-81c7-409a-8cb1-26d66be790af 36 fields · synced Jun 1, 2026