AccessGUDID - DEVICE: Busse Hospital Disposables (00849233018105)

GUDID

Device Identifier (DI) Information

Brand Name: Busse Hospital Disposables
Version or Model: 385
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 385
Company Name: ROBERT BUSSE & CO., INC.

Primary DI Number: 00849233018105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002418234 *Terms of Use

Device Description: Umbilical Cord Clamp, Bulk

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):	No
Over the Counter (OTC):	Yes
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?
43998	Umbilical cord clamp, single-use	A sterile, hand-held manual surgical instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating (e.g., with a clip) the cord, and is intended to enable aseptic haemostasis. It is typically made of plastic material and may incorporate features such as serrations on the contact area and/or a security lock. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFW	Clamp, Umbilical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010835	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 976ff449-e9de-4887-bc97-f06bac929448
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 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
10849233018102	250	00849233018105		In Commercial Distribution

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 (631) 435-4711
Email: mail@busseinc.com

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