DEVICE: BD Eclipse (00382903057689)

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Device Record History
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Device Identifier (DI) Information
BD Eclipse
305768
In Commercial Distribution
305768
BECTON, DICKINSON AND COMPANY
00382903057689
GS1

1
001292192 *Terms of Use
NEEDLE ECLIPSE 22X1 RB
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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?
59230 Hypodermic needle, single-use
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly 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 [?]
K010188 000
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Room Temperature
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Clinically Relevant Size

[?]
Size Type Text
Height: 1 Inch
Needle Gauge: 22 Gauge
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Device Record Status
b679ff6a-c5bf-4f45-85e7-1ad8f3188f2c
July 17, 2025
7
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50382903057684 12 30382903057680 In Commercial Distribution Case
30382903057680 100 00382903057689 In Commercial Distribution Shelfpack
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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

[?]
No Customer Contact currently defined
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