FDA.reportPublic FDA data

BluWing

Primary DI
10850011007256
Brand
BluWing
Company
MERCEDES MEDICAL, LLC
Model
MER 1921
Catalog number
MER 1921
Device description
Safety Blood Collection Set 21g
Published
2017-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00850011007259PackageGS150In Commercial Distribution
10850011007256PackageGS120In Commercial Distribution
00850011007228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011007259008500110072598500110072590850011007259
1085001100725610850011007256
00850011007228008500110072288500110072280850011007228

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive device/collection of devices which includes a sharp and rigid needle intended to puncture a vein to collect blood and/or for transient (<24 hours) administration of intravenous (IV) fluids. The needle includes wings for fixation/placement and may include tubing/connectors; it is not, and does not include, a peripheral catheter. The device may be referred to as a 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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003312716mmcwhorter@mercedesmedical.com

Regulatory Flags#

DUNS number
834472680
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011007228BluWingMER 1921MER 19212017-07-01
00850011007235BluWingMER 1923MER 19232017-07-01
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

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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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00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE 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
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26