GLUCO-CARE Safety Lancets 30G x 1.8 mm

FDA UDI

Class II (US FDA UDI)

by MediVena, LLC

Identity

Trade Name: GLUCO-CARE Safety Lancets 30G x 1.8 mm FDA UDI
Generic Name: Manual blood lancing device, single-use FDA UDI
Device Name: MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. GLUCO-CARE Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap, then pull it out, STEP 2 Press the color-coded main housing to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container. FDA UDI
Model / Reference: GLUCO-CARE Safety Lancets 30G x 1.8 mm FDA UDI
Description: MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. GLUCO-CARE Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap, then pull it out, STEP 2 Press the color-coded main housing to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container. FDA UDI

Identifiers

Catalog Number: 1111 FDA UDI
Primary DI / UDI-DI: 00810008214381 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Manual blood lancing device, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 30 Gauge FDA UDI
Length — 1.8 Millimeter FDA UDI

Category: Manual blood lancing device, single-use

GLUCO-CARE Safety Lancets 30G x 1.8 mm by MediVena, LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: MediVena, LLC

Sources (1)

FDA UDI 4e244d80-8b25-465c-8313-80e6f6043adf 37 fields · synced May 30, 2026