Abena

GUDID 05713571001134

Abena Man Formula 1, Premium holds15 fl oz/450 ml, product size L x W= 11 x 9"

Abena North America, Inc

Absorbent underpad, non-antimicrobial, single-use

• Primary Device ID: 05713571001134
• NIH Device Record Key: 8035783a-c93f-4d26-a6b7-d363e32d594f
• Commercial Distribution Discontinuation: 2026-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abena
• Version Model Number: 1000021335
• Company DUNS: 078740398
• Company Name: Abena North America, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com
• Phone: 844-223-6248
• Email: info-na@abena.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store dry, room temperature and no direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713571001127 [Primary]
GS1	05713571001134 [Package]; Contains: 05713571001127; Package: case [12 Units]; Discontinued: 2026-01-01; In Commercial Distribution

FDA Product Code

• EYQ: Garment, Protective, For Incontinence

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: 2023-03-22
• Device Publish Date: 2023-03-14

On-Brand Devices [Abena]

• 05713571001271: Abena Light Super 4, Premium holds 29 fl oz/850 ml, product size L x W=16.5 x 7"
• 05713571001257: Abena Light Extra Plus 3A, Premium holds 22 fl oz/650 ml, product size L x W= 13 x 4"
• 05713571001233: Abena Light Extra 3, Premium holds 17 fl oz/500 ml, product size L x W= 13 x 4"
• 05713571001219: Abena Light Normal 2, Premium holds 12 fl oz/350 ml, product size L x W= 10 x 4"
• 05713571001196: Abena Light Mini Plus 1A, Premium holds 7 fl oz/200 ml, product size L x W= 11 x 4"
• 05713571001172: Abena Light Mini 1, Premium holds 6 fl oz/180 ml, product size L x W= 9 x 4"
• 05713571001158: Abena Man Formula 2, Premium holds 24 fl oz/700 ml, product size L x W=11 x 9"
• 05713571001134: Abena Man Formula 1, Premium holds15 fl oz/450 ml, product size L x W= 11 x 9"
• 05703538461323: Abena Man Slipguard, Premium holds 30 fl oz/900 ml, product size L x W=3.5 x 16"
• 05703538459030: Abena Light Maxi 4A, Premium holds 34 fl oz/1000 ml, product size L x W= 16 x 6"
• 05703538459016: Abena Light Ultra Mini 0, Premium holds 2.71 fl oz/ 80 ml, product size L x W= 7.5 x 3"
• 05713571001318: Abena Let Mini holds 17 fl oz/500 ml, product size L x W = 5.5 x 15"
• 05713571001103: Abena Man Formula 0, Premium, holds 10 fl oz/300 ml, product size L x W = 9.05 x 7.48
• 05713571001097: Abena Man Special, Premium holds 95 fl oz/2800 ml, product measurements are 14.5 x 29" (width an
• 05713571001066: Abena Pants Light L, holds 30 fl oz/900 ml, product size L x W = 36.22 x 30.7
• 05713571001042: Abena Pants Light M, holds 30 fl oz/900 ml, product size L x W = 32.28 x 26.77
• 05703538461422: Abena Let Maxi, holds 37 fl oz/1100 ml, product size L x W = 23.62 x 5.9
• 05703538461309: Abena Man Zero, Premium holds 7 fl oz/200 ml, product measurements are 7.3 x 7" (width x length)
• 05703538458415: Abena Pants XXL1, Premium holds 51 fl oz/1500 ml, hip and waist measurements for 59-80".
• 05713571001325: Abena Let Anatomic, holds 17 fl oz/500 ml, product size L x W = 17.32 x 7.87
• 05713571001288: Abena Let Normall holds 17 fl oz/500 ml, product size L x W = 15.35 x 5.51
• 05713571002001: Abena Maternity Pad Incontinence holds 28 fl oz and its meant for Women during pregnancy and pos
• 05703538479007: ABENA Slip Flexi Fit L-XL4, Premium holds 4000ml/135 fl oz, hip size 43.3"- 66.93"
• 05703538478963: ABENA Slip Flexi Fit M-L4, Premium holds 3600ml/122 fl oz, hip size 70-120 cm/27.56"- 47.24"
• 05703538479021: ABENA Nova Slip S2, Premium holds 60 fl oz/ 1800ml, hip size 23.62''- 33.46''
• 05703538478987: ABENA Nova Slip Flexi Fit L-XL2, Premium holds 104 fl oz/ 3100 ml, hip size 43.3"- 66.93"
• 05703538478949: ABENA Nova Slip Flexi Fit M-L2, Premium holds 87 fl oz/ 2600ml, hip size 27.56"- 47.24"
• 05703538479083: ABENA Nova San 10, premium holds 94 fl oz/ 2800ml
• 05703538479069: ABENA Nova San 7, Premium holds 71 fl oz/ 2100ml
• 05703538479045: ABENA Nova San 6, premium holds 54 fl oz/1600ml