Hemaprep

FDA UDI

Class I (US FDA UDI)

by J.p. Gilbert Co.

Identity

Trade Name: Hemaprep FDA UDI
Generic Name: Microscope slide maker IVD FDA UDI
Device Name: Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required. FDA UDI
Model / Reference: 756300 FDA UDI
Description: Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required. FDA UDI

Identifiers

Catalog Number: 756300 FDA UDI
Primary DI / UDI-DI: 00860010522301 FDA UDI
FDA Product Code: GKJ FDA UDI
GMDN Term: Microscope slide maker IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.5850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 5.4 Inch FDA UDI
Depth — 6.3 Inch FDA UDI
Width — 3.5 Inch FDA UDI

Category: Microscope slide maker IVD

Hemaprep by J.p. Gilbert Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: J.p. Gilbert Co.

Sources (1)

FDA UDI 25ad61db-f412-459f-bda9-1ff043c8b2f1 37 fields · synced May 30, 2026