Albahealth

GUDID 50073614778943

12" X 48" IMPERVIOUS

Albahealth, LLC

Patient surgical drape, single-use, sterile Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use

• Primary Device ID: 50073614778943
• NIH Device Record Key: 3a46d118-8600-4186-9096-08cd09513c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Albahealth
• Version Model Number: 091248009990902
• Company DUNS: 003375805
• Company Name: Albahealth, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073614778948 [Primary]
GS1	50073614778943 [Package]; Contains: 00073614778948; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792357

FDA Product Code

• KKX: Drape, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Albahealth]

• 50073614793564: 2X-LARGE-LONG THIGH
• 50073614793557: 3X-LARGE-REGULAR THIGH
• 50073614793540: 2X-LARGE-REGULAR THIGH
• 50073614793533: 2X-LARGE-SHORT THIGH
• 50073614793526: XLARGE-SHORT THIGH
• 50073614793519: 2X-LARGE-LONG KNEE
• 50073614793502: 3X-LARGE-REGULAR KNEE
• 50073614793496: 2X-LARGE-LONG KNEE
• 50073614793489: 2XLARGE-SHORT KNEE
• 50073614793472: X-LARGE-SHORT KNEE
• 50073614793465: LARGE-SHORT KNEE
• 50073614793458: MEDIUM-SHORT KNEE
• 50073614793441: SMALL-SHORT KNEE
• 50073614789253: 2X LARGE SHORT KNEE
• 50073614789246: XLARGE-SHORT KNEE
• 50073614789239: LARGE-SHORT KNEE
• 50073614789222: MEDIUM-SHORT KNEE
• 50073614789208: 2X LARGE-LONG KNEE
• 50073614789185: 2XLARGE-LONG THIGH
• 50073614789178: 2XLARGE-REGULAR THIGH
• 50073614789161: 2XLARGE-SHORT THIGH
• 50073614789130: XLARGE-REGULAR THIGH
• 50073614789123: 3X LARGE-REGULAR KNEE
• 50073614789116: 2X LARGE-REGULAR KNEE
• 50073614789093: LARGE-LONG THIGH
• 50073614789086: LARGE-REGULAR THIGH
• 50073614789079: LARGE-SHORT THIGH
• 50073614789055: MEDIUM-REGULAR THIGH
• 50073614789048: MEDIUM-SHORT THIGH
• 50073614789031: SMALL-LONG THIGH
• 50073614789024: SMALL-REGULAR THIGH
• 50073614788966: EX. LARGE-REGULAR KNEE
• 50073614788959: LARGE-REGULAR KNEE
• 50073614788935: SMALL-REGULAR KNEE
• 50073614786818: ESSENTIAL CARE 2X-LARGE LONG T
• 50073614786801: ESSENTIAL CARE 2X-LARGE REGULA
• 50073614786795: ESSENTIAL CARE SMALL-SHORT KNE
• 50073614786788: ESSENTIAL CARE 2XLARGE SHORT T
• 50073614786771: ESSENTIAL CARE 3X-LARGE REGULA
• 50073614786764: ESSENTIAL CARE 2X-LARGE LONG K
• 50073614786757: ESSENTIAL CARE 3X-LARGE REGULA
• 50073614786740: ESSENTIAL CARE 2X-LARGE SHORT
• 50073614786726: ESSENTIAL CARE LARGE SHORT KNE
• 50073614786719: ESSENTIAL CARE MEDIUM-SHORT KN
• 50073614786702: ESSENTIAL CARE 2X-LARGE REGULA
• 50073614783503: ULTRACARE BAS ANTI-EMBOLIE, X-
• 50073614783497: ULTRACARE BAS ANTI-EMBOLIE, LA
• 50073614783480: ULTRACARE BAS ANTI-EMBOLIE, MO
• 50073614783473: ULTRACARE BAS ANTI-EMBOLIE, PE
• 50073614783466: ULTRACARE BAS ANTI-EMBOLIE, X-