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.
00646311400094
GS1
December 31, 2023
1
690625850 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 27 Gauge
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Device Record Status

b0b27c9c-3772-434c-9898-227870ee00fb
February 05, 2024
8
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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(813) 630-5554
info@kawasumiamerica.com
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