DEVICE: Tamper Evident Cap (B21257351R1)

Device Identifier (DI) Information

Tamper Evident Cap
57-351 R
In Commercial Distribution
57-351 R
INTERNATIONAL MEDICAL INDUSTRIES INC.
B21257351R1
HIBCC

10
053469565 *Terms of Use
"Sterile Red Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility. Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per box."
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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?
16825 Syringe tip cap
A device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K861276 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

65e4ccbc-f8a7-4570-a590-d5adc244c70e
February 21, 2020
1
February 13, 2020
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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
B21257351R2 70 B21257351R1 In Commercial Distribution Box
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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: B21257351R0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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