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Rusch

FDA UDI

Class II (US FDA UDI)

by B.L.S. Systems Limited

Identity

Trade Name
RUSCH FDA UDI
Generic Name
Pulmonary resuscitator, manual, single-use FDA UDI
Device Name
Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and medium mask FDA UDI
Model / Reference
157100100 FDA UDI
Description
Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and medium mask FDA UDI

Identifiers

Catalog Number
157100100 FDA UDI
Primary DI / UDI-DI
00627843557524 FDA UDI
510(k) Number
K993194 FDA UDI
FDA Product Code
BTM FDA UDI
GMDN Term
Pulmonary resuscitator, manual, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5915 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Rusch by B.L.S. Systems Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K993194 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B.L.S. Systems Limited

Sources (1)

  • FDA UDI f50098ea-7d72-4cbd-a48f-46dc9ff6bc50 39 fields · synced May 30, 2026