AccessGUDID - DEVICE: ARROW (10816000012465)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN033743
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9058
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10816000012465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: EZ-IO(R) Power Driver

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62075	Intraosseous-access handpiece, infusion, electric	A hand-held, battery-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, hypodermic, single lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141117	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Power driver and accessories should be stored at temperatures between -20°C to 50°C (-4°F to 122°F)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 19516765-dd99-41cb-86a0-f0eabf2f8504
Public Version Date: June 11, 2020
Public Version Number: 7
DI Record Publish Date: September 23, 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
40816000012466	25	10816000012465	2020-06-09	Not in Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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