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Blue Series - EF

FDA UDI

Class II (US FDA UDI)

by Respire Medical Holdings

Identity

Trade Name
Blue Series - EF FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
Respire Blue Series EF FDA UDI
Model / Reference
SB030US FDA UDI
Description
Respire Blue Series EF FDA UDI

Identifiers

Primary DI / UDI-DI
00851861007024 FDA UDI
510(k) Number
K152292 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Circumference — 200 Millimeter FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

Blue Series - EF by Respire Medical Holdings — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Cleared under the same submission

K152292 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respire Medical Holdings

Sources (1)

  • FDA UDI 8f55a0d5-ed8a-424f-b98c-9a95b2e57ba0 36 fields · synced May 31, 2026