INDALJIMTM

GUDID 07506561200048

Indaljim, S.A. de C.V.

Isolation gown, single-use

• Primary Device ID: 07506561200048
• NIH Device Record Key: 35515ac2-179c-40d2-8e30-2b8d035596eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INDALJIMTM
• Version Model Number: BS35-L
• Company DUNS: 812753058
• Company Name: Indaljim, S.A. de C.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07506561200048 [Primary]

FDA Product Code

• FXO: Suit, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [INDALJIMTM]

• 07506561200277: BE-01
• 07506561200260: OV-XL
• 07506561200253: OV-L
• 07506561200246: OV-M
• 07506561200239: BMD-XL
• 07506561200222: BMD-L
• 07506561200215: BMD-M
• 07506561200130: C3C-01
• 07506561200062: GR-01
• 07506561200055: BS35-XL
• 07506561200048: BS35-L
• 07506561200031: BS35-M
• 07506561200024: BS25-XL
• 07506561200017: BS25-L
• 07506561200000: BS25-M