ACS

GUDID 00191072107268

#1 SPECIMEN TUBE PK,STRL F/G (PS 907131)

AMERICAN CONTRACT SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00191072107268
• NIH Device Record Key: f57df33b-92b7-4899-843f-a2b1bcb6b684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACS
• Version Model Number: UIST11F
• Company DUNS: 010334675
• Company Name: AMERICAN CONTRACT SYSTEMS, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00191072107268 [Primary]

FDA Product Code

• OFZ: Blood specimen collection kit (excludes HIV testing)

Sterilization

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

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

[00191072107268]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-14
• Device Publish Date: 2020-04-06

On-Brand Devices [ACS]

• 00191072000057: OUTPATIENT PORT ACCESS KIT
• 00191072000040: LABOR DELIVERY PACK - 213387
• 00191072000033: C-SECTION PACK 2 - 242901
• 00191072000026: C-SECTION PACK - 205965
• 00191072000019: CLEAN CLOSURE PACK - 289126
• 00191072000002: STANDARD ARTHROSCOPY PACK - 291852
• 00191072000071: LEVEL 1 PPE KIT (REV 3)NONSTERILE-277567
• 00191072000064: LEVEL 2A PPE KIT(REV 4)NONSTERILE-288133
• 00191072033383: T&A PACK
• 00191072032652: PROMEDICA BARRIER KIT
• 00191072032478: CNRV PERIPHERAL VAS
• 00191072032447: CNRV MAJ LITH/LAVH ACC
• 00191072032416: CNRV LITHOTOMY
• 00191072032348: CNRV GYN LAP
• 00191072032324: CNRV CAROTID ACCESS
• 00191072031983: GU-GYN-LITHO PACK
• 00191072031921: CV PACK
• 00191072031419: PEDS HEART DONOR PACK
• 00191072031075: ADULT HEART DONOR PACK
• 00191072030986: ER PELVIC KIT
• 00191072030948: D & C PACK
• 00191072030634: KNEE ARTHROSCOPY
• 00191072030573: TOTAL KNEE
• 00191072030566: SHOULDER PACK
• 00191072030535: LAP CHOLE PACK
• 00191072030221: BARRIER PACK
• 00191072030153: OPEN HEART A PACK
• 00191072030054: CDC COMPLIANCE KIT
• 00191072029560: CMC POSTERIOR HIP PACK
• 00191072029546: VALVE REPLACEMENT
• 00191072029348: CMC TOTAL KNEE
• 00191072029324: ANTERIOR HIP PACK
• 00191072029287: CMC LABOR AND DELIVERY
• 00191072029126: CORONARY BYPASS
• 00191072029072: BREAST PROCEDURE
• 00191072028075: BIOPSY TRAY
• 00191072027672: T & A PACK VARNER PACL
• 00191072027658: RADIOLOGY DRAPE PACK
• 00191072027597: MAJOR LITHOTOMY PACK
• 00191072027573: KYPHOPLASTY PACK
• 00191072026927: ACDF
• 00191072025586: HEART CABG
• 00191072024800: TONSILS AND ADNOIDS
• 00191072024251: VASCULAR PACK
• 00191072024206: PAIN PACK
• 00191072024190: OB GYN LAPAROSCOPIC TRAY
• 00191072024169: HYSTEROSCOPY PACK
• 00191072024039: RADIOLOGY ARTERIOGRAM PACK
• 00191072023964: LAVH
• 00191072023933: CUSTOM HEART PACK II