AccessGUDID - DEVICE: micsafe (06971911291518)

GUDID

Device Identifier (DI) Information

Brand Name: micsafe
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jiangsu Micsafe Medical Tehcnology Co.,LTD.

Primary DI Number: 06971911291518
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554400604 *Terms of Use

Device Description: BLOOD COLLECTION WITH NEEDLE

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?
58284	Blood collection tube holder/needle	A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212019	000

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
No Device Sizes

Device Record Status

Public Device Record Key: f7e7ec9d-1898-493f-8cbb-4f200ff933ef
Public Version Date: June 08, 2023
Public Version Number: 1
DI Record Publish Date: May 31, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
16971911291515	100	06971911291518		In Commercial Distribution	BOX
26971911291512	1000	06971911291518		In Commercial Distribution	CASE

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

[?]

No Customer Contact currently defined

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