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Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Low Flow) (Kit 3)

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Low Flow) (Kit 3) FDA UDI
Generic Name
Carpal lunate prosthesis FDA UDI
Model / Reference
038-33-255U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788770039 FDA UDI
FDA Product Code
BTT FDA UDI
BZE FDA UDI
GMDN Term
Carpal lunate prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5450 FDA UDI
868.5270 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Carpal lunate prosthesis

Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Low Flow) (Kit 3) by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Carpal lunate prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flexicare Medical Limited

Sources (1)

  • FDA UDI f5cd3a7a-1f61-4318-8429-237542c04779 32 fields · synced May 30, 2026