DEVICE: WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER (00646311400094)
Device Identifier (DI) Information
WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER
DBM1-27G
Not in Commercial Distribution
DBM1-27G
SB-KAWASUMI LABORATORIES, INC.
DBM1-27G
Not in Commercial Distribution
DBM1-27G
SB-KAWASUMI LABORATORIES, INC.
Winged Collection Set with Multi-Sample Luer Adapter is a sterile, single use device with a needle and wing used for venipuncture and a luer adapter with a needle used for blood sample collection into a vacuum tube or culture medium vial.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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58497 | Blood collection set, invasive |
A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Needle Gauge: 27 Gauge |
Device Record Status
b0b27c9c-3772-434c-9898-227870ee00fb
February 05, 2024
8
September 20, 2016
February 05, 2024
8
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(813) 630-5554
info@kawasumiamerica.com
info@kawasumiamerica.com