Primo

FDA UDI

Class I (US FDA UDI)

by Asp Global, LLC

Identity

Trade Name: PRIMO FDA UDI
Generic Name: Multiple haemoglobin subtype IVD, control FDA UDI
Device Name: Glide & Guide Rounded Wedge Bundle - 1 each - 36" x 60" Glide & Guide Turn Sheet (No Straps), 1 each 15" Long and 19" Long Rounded Wedges FDA UDI
Model / Reference: GGTS01 FDA UDI
Description: Glide & Guide Rounded Wedge Bundle - 1 each - 36" x 60" Glide & Guide Turn Sheet (No Straps), 1 each 15" Long and 19" Long Rounded Wedges FDA UDI

Identifiers

Primary DI / UDI-DI: 00840216113688 FDA UDI
FDA Product Code: FMP FDA UDI
GMDN Term: Multiple haemoglobin subtype IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple haemoglobin subtype IVD, control

Primo by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CueSee® CO-OX — Eurotrol B.V. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Asp Global, LLC

Sources (1)

FDA UDI ad9a938a-76d7-4f25-b537-0b574cb2dfd6 33 fields · synced May 31, 2026