FDA.reportPublic FDA data

BluWing

Primary DI
00850011007235
Brand
BluWing
Company
MERCEDES MEDICAL, LLC
Model
MER 1923
Catalog number
MER 1923
Device description
Safety Blood Collection Set 23g
Published
2017-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163093000Safety Blood Collection SetJiangsu Shenli Medical Production Co., Ltd.2017-03-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011007266PackageGS150In Commercial Distribution
10850011007263PackageGS120In Commercial Distribution
00850011007235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011007266008500110072668500110072660850011007266
1085001100726310850011007263
00850011007235008500110072358500110072350850011007235

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
800-331-2716mmcwhorter@mercedesmedical.com

Regulatory Flags#

DUNS number
834472680
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011007228BluWingMER 1921MER 19212017-07-01
00850011007242BluWingMER 1925MER 19252017-07-01
00850011007143Tanner Scientific®TNR 10SGTNR 10SG2016-08-15
00850011007280BluRapidsTNR CDOA6125MTNR CDOA6125M2017-08-09
00850011007174Tanner Scientific®TNR HCGCOMBOTNR HCGCOMBO2016-08-22
00860008185136BluTouchTNR 700XLTNR 700XL2023-05-15
00860008185112BluTouchTNR 700LTNR 700L2023-05-15
10860008185133BluTouchTNR 700XLTNR 700XL2023-05-15
00860008185105BluTouchTNR 700STNR 700S2022-12-28
00860008185129BluTouchTNR 700MTNR 700M2022-12-28
00850011007129Tanner Scientific®TNR DOA12ATNR DOA12A2016-08-15
00850011007136Tanner Scientific®TNR DOA13ATNR DOA13A2016-08-15
00850011007310Platinum+MER HCDOAY6125MER HCDOAY61252018-03-30
00850011007570Platinum+MER MMDOAY6125MER MMDOAY61252018-08-10
00850011007068BluRapids™TNR CDOA6125TNR CDOA61252016-08-15
00850011007075BluRapids™TNR CDOA5125A3TNR CDOA5125A32016-08-15
00850011007082BluRapids™TNR CDOA7125TNR CDOA71252016-08-15
00850011007099BluRapids™TNR MMC12MOPTNR MMC12MOP2016-08-15
00850011007105BluRapids™TNR CDOA2135TNR CDOA21352016-08-15
00850011007112BluRapids™TNR CDOA7125A3TNR CDOA7125A32016-08-15

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Primary DI, Brand, Company table
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MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00850068519361SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519378SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519385SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
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