AccessGUDID - DEVICE: ARROW (00801902011527)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN040168
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LR-05501
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 00801902011527
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: 10 mL Luer-Slip Loss of Resistance Syringe

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:	Yes
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?
60116	DNA-based tissue typing IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes. Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 0 Centimeter

Device Record Status

Public Device Record Key: 90d82dfa-aceb-437e-8501-277732de7d69
Public Version Date: March 04, 2020
Public Version Number: 3
DI Record Publish Date: September 16, 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
30801902011528	25	00801902011527	2020-03-03	Not in Commercial Distribution	Box

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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