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Perry Sigma Monoplace

FDA UDI

Class II (US FDA UDI)

by Perry Baromedical Corporation

Identity

Trade Name
Perry Sigma Monoplace FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
HYPERBARIC SYSTEM, 34" MONOPLACE CHAMBER WITH UNDERCARRIAGE FDA UDI
Model / Reference
Sigma 34 w/Undercarriage FDA UDI
Description
HYPERBARIC SYSTEM, 34" MONOPLACE CHAMBER WITH UNDERCARRIAGE FDA UDI

Identifiers

Primary DI / UDI-DI
00852678007108 FDA UDI
510(k) Number
K990927 FDA UDI
FDA Product Code
CBF FDA UDI
GMDN Term
Hyperbaric chamber, stationary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5470 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 2400 Pound FDA UDI
Height — 65.45 Inch FDA UDI
Length — 105 Inch FDA UDI
Width — 40 Inch FDA UDI

Category: Hyperbaric chamber, stationary

Perry Sigma Monoplace by Perry Baromedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Cleared under the same submission

K990927 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perry Baromedical Corporation

Sources (1)

  • FDA UDI b957baaf-149c-4f5b-bb08-b31b9ff337c1 36 fields · synced Jun 9, 2026