FDA.reportPublic FDA data

DANLEE MEDICAL KIT

Primary DI
00816310020061
Brand
DANLEE MEDICAL KIT
Company
DANLEE MEDICAL PRODUCTS, INC
Model
CARSLN240
Device description
LANCETS (ZKIT)
Published
2016-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816310020061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816310020061008163100200618163100200610816310020061

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
878130871
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816310023840DANLEE MEDICAL KITSAMPLE AMBU R SERIESS0B2S7ABWS2026-02-13
00816310023833DANLEE MEDICAL KIT470-0104-012025-10-28
00816310023826DANLEE MEDICAL KITCK-002-NRB2025-03-13
00816310023819DANLEE MEDICAL KITD022S5AB-1D022S5AB-12024-10-30
00816310023802DANLEE MEDICAL KITD0B1G5AB-12024-10-10
00816310023796DANLEE MEDICAL KITS000G5DDAS2024-10-09
00816310023789DANLEE MEDICAL KITD000S5ABUVZ2024-08-06
00816310023772DANLEE MEDICAL KITS000P5DDABWGG2024-06-14
00816310023758DANLEE MEDICAL KITD0B1S7ABUV2024-02-21
00816310023765DANLEE MEDICAL KITS0B1S52024-02-21
00816310023741DANLEE MEDICAL KITHTC-0012023-12-14
00816310023734DANLEE MEDICAL KITS00000AGG2023-07-14
00816310023727DANLEE MEDICAL KITD022G5ABKV2023-04-25
00816310023710DANLEE MEDICAL KITD0B1P7ABV2023-04-05
00816310023703DANLEE MEDICAL KITMED6G022G5ABV2023-03-31
00816310023697DANLEE MEDICAL KITD0B1P7AVZ2023-03-14
00816310023680DANLEE MEDICAL KITGS021G5ABUVW2023-01-23
00816310023666DANLEE MEDICAL KITGS000G5ABUVW2022-10-03
00816310023673DANLEE MEDICAL KITG0B1G5AV2022-10-03
00816310023659DANLEE MEDICAL KITS0B2S5ABMSW2022-09-20